Non-AI PCCPs
64 of the 143 FDA-authorized PCCPs in this tracker are Non-AI. Here is the full list, newest first.
- K254102GlucommanderGlytec, LLC2026-05-27Non-AIChange management
- K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics2026-05-11Non-AIUnknown
- K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026-04-21Non-AIPanel expansion
- K260216CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-04-21Non-AII/O expansion
- K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17Non-AIPanel expansion
- K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026-04-15Non-AIUnknown
- K260812Francisella tularensis Real-time PCR AssayCenters for Disease Control and Prevention2026-03-30Non-AIUnknown
- K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX2026-03-26Non-AIUnknown
- K253743MiniMed Flex pumpMedtronic Minimed, Inc.2026-03-12Non-AII/O expansion
- K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.2026-02-13Non-AIUnknown
- K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.2026-02-04Non-AIOther
- K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC2026-01-09Non-AIOther
- K243342KP Protective Face MaskKp Trading Co., Ltd.2025-12-22Non-AIUnknown
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG2025-12-18Non-AIOther
- K243449INFINITT DPSInfinitt Healthcare Co., Ltd.2025-12-09Non-AIUnknown
- K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)2025-12-05Non-AIUnknown
- K252762HALO AP DxIndica Labs, LLC2025-11-25Non-AICompatibility expansion
- K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics2025-11-20Non-AIUnknown
- K250392ZAP-X Radiosurgery System (ZAP-X)Zap Surgical Systems, Inc.2025-11-03Non-AII/O expansion
- K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC2025-10-27Non-AIUnknown
- K252357Glucose2Abbott Ireland2025-10-24Non-AICompatibility expansion
- K253331PressON Spinal Fixation SystemNexus Spine2025-10-14Non-AIUnknown
- K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC2025-10-10Non-AIOther
- K252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLLiofilchem s.r.l.2025-10-02Non-AIUnknown
- K252072Francisella tularensis Real-time PCR assayCenters for Disease Control and Prevention2025-09-30Non-AICompatibility expansion
- K252062The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mLThermo Fisher Scientific2025-09-25Non-AIUnknown
- K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)Vitacore Industries, Inc.2025-09-17Non-AIOther
- K250575The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mLThermo Fisher Scientific2025-09-05Non-AIUnknown
- K252014The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mLThermo Fisher Scientific2025-08-28Non-AIUnknown
- K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.2025-08-21Non-AIUnknown
- K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.2025-08-20Non-AIUnknown
- K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)Liofilchem s.r.l.2025-08-20Non-AIUnknown
- K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.2025-08-15Non-AIUnknown
- K251519RelieVRx (Pico G3)Appliedvr2025-08-13Non-AIHardware
- K251879Sulopenem SPM 2 µgLiofilchem2025-08-12Non-AIUnknown
- K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company2025-08-08Non-AIOther
- K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.2025-07-18Non-AIUnknown
- K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)Centers for Disease Control and Prevention2025-07-11Non-AII/O expansion
- K250524Mendaera Guidance SystemMendaera, Inc.2025-07-02Non-AICompatibility expansion
- K251032MiniMed 780G insulin pumpMedtronic Minimed, Inc.2025-07-01Non-AICompatibility expansion
- K250990The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mLThermo Fisher Scientific2025-06-30Non-AIUnknown
- K243391AISight DxPathAI, Inc.2025-06-26Non-AICompatibility expansion
- K250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics2025-06-26Non-AIUnknown
- K250885Ceftobiprole BPR 5 µg DiscLiofilchem, Inc.2025-06-23Non-AIUnknown
- K242843The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.Thermo Fisher Scientific2025-06-20Non-AIUnknown
- K250968PathPresenter Clinical ViewerPathpresenter Corporation2025-06-20Non-AIUnknown
- K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation2025-06-12Non-AIUnknown
- K250856ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)Biomérieux2025-06-12Non-AIUnknown
- K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50Thermo Fisher Scientific (Oxoid Ltd.)2025-06-12Non-AIUnknown
- K242659The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mLThermo Fisher Scientific2025-05-22Non-AIUnknown
- K250447BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company2025-05-19Non-AIOther
- K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)Hardy Diagnostics2025-05-15Non-AIUnknown
- K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A.2025-04-30Non-AIUnknown
- K242658The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mLThermo Fisher Scientific2025-04-15Non-AIUnknown
- K243943TriMed® Compression ScrewsTriMed, Inc.2025-04-10Non-AIOther
- K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.2025-04-02Non-AIUnknown
- K243987TriMed Elbow and Forearm SystemTriMed, Inc.2025-03-19Non-AIUnknown
- K243999TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19Non-AIHardware
- K250079Ruby XL SystemPenumbra, Inc.2025-03-14Non-AIUnknown
- K242244Viewer+Lumea, Inc.2025-03-14Non-AIUnknown
- K243738The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mLThermo Fisher Scientific2025-02-27Non-AIUnknown
- K242905The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mLThermo Fisher Scientific2025-02-10Non-AIUnknown
- K243201The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mLThermo Fisher Scientific2025-02-10Non-AIUnknown
- K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation2025-01-13Non-AIUnknown
Other categories
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We read the Non-AI PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.