510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K242758 | Atrauman® Ag | Hartmann USA, Inc | FRO | Unclassified | |
| K242729 | AutoContour (Model RADAC V4) | Radformation, Inc. | QKB | Class II | |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | HKI | Class II | |
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences LLC | DYG | Class II | |
| K240841 | Digital Radiography System (ManntiX B, ManntiX K) | Shenzhen Browiner Tech Co., Ltd. | IZL | Class II | |
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH | JEH | Class II | |
| K240700 | HomeSleepTest (HST, HST REM+) | Somnomedics AG | OLV | Class II | |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | LHI | Class II | |
| K243073 | AnyPlus Navigated Instruments System | GS Medical Co., Ltd. | OLO | Class II | |
| K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific Corporation | FGE | Class II | |
| K242824 | PTFE Guidewire | Lake Region Medical | DQX | Class II | |
| K242710 | Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | Boston Scientific Corporation | OAB | Class II | |
| K242645 | INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant | Project Chemistry, Inc. | NUC | Class II | |
| K242524 | SyMRI | Syntheticmr AB (Publ.) | LNH | Class II | |
| K242304 | Red | Neuraxis, Inc | KLA | Class II | |
| K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical a/S | LLZ | Class II | |
| K241946 | PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Bard Peripheral Vascular Inc | PNG | Class II | |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.Ai, Co., Ltd. | QAS | Class II | |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | Stryker Corporation (Tornier, Inc.) | KWS | Class II | |
| K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | Abbott Molecular, Inc. | QQX | Class II | |
| K241567 | MC2 Portable X-ray System | Oxos Medical Inc | OWB | Class II | |
| K241543 | DrAid™ for Liver Segmentation | Vinbrain Joint Stock Company | QIH | Class II | |
| K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | HSX | Class II | |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | PENTAX of America, Inc. | FDS | Class II | |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | MAX | Class II | |
| K240971 | 87 NeuGlide Catheter | Piraeus Medical, Inc. | QJP | Class II | |
| K240926 | PeekMed web | Peek Health, S.A. | LLZ | Class II | |
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | CAW | Class II | |
| K240680 | CDM Insights | Oxford Brain Diagnostics, Ltd. | QIH | Class II | |
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products Inc | CAW | Class II | |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | PLF | Class II | |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | MQV | Class II | |
| K243463 | BIOFIRE FILMARRAY Tropical Fever Panel | Biofire Diagnostics, LLC (Biomerieux) | QMV | Class II | |
| K243447 | Rapid Surgical Plan (RSP-SW-001) | Navbit Pty Ltd | LLZ | Class II | |
| K243444 | Bioceram Azul® Head | Kyocera Corporation | LZO | Class II | |
| K243435 | Magnetic Localization Patch Kit (AFR-00021) | Medtronic, Inc. | DQK | Class II | |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co.,Ltd. | EIH | Class II | |
| K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | NHA | Class II | |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K242525 | iTOF® | Nerbio Medical Software Platforms, Inc. | KOI | Class II | |
| K241674 | Osteopal® V | Heraeus Medical GmbH | LOD | Class II | |
| K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | HRS | Class II | |
| DEN240025 | VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) | Ventana Medical Systems Inc | SDP | Class II | |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | JOJ | Class II | |
| K243417 | RelieVRx | Appliedvr | QRA | Class II | |
| K243265 | Ion 3D | Surgentec LLC | MRW | Unclassified | |
| K243180 | SSPC NXT Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Howmedica Osteonics Corp., dba Stryker Orthopaedics | JWH | Class II | |
| K242686 | Neodent Implant System | Jjgc Indústria E Comércia de Materiais Dentários S.A. | NHA | Class II |