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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K231367 | Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. | DXN | Class II | |
| K223835 | Ma-40, Ma-112 | Medify Air, LLC | FRF | Class II | |
| K222251 | B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | B.R.A.H.M.S GmbH, Part of Thermo Fisher | QXS | Class II | |
| K231688 | ImPACT Version 4 | Impact Applications, Inc. | POM | Class II | |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | CAH | Class II | |
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care, US LLC | DWJ | Class II | |
| K232315 | Catalyst Bone Void Filler | Ossdsign | MQV | Class II | |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) | Zhenjiang Assure Medical Equipment Co Ltd | IOR | Class I | |
| K232198 | Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) | Zhenjiang Assure Medical Equipment Co Ltd | IOR | Class I | |
| K232121 | Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co., Ltd | ITI | Class II | |
| K232102 | ClearPoint Array System (Version 1.2) | ClearPoint Neuro Inc. | HAW | Class II | |
| K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, S.L. | NHA | Class II | |
| K231791 | PENTO Nd:YAG and Alexandrite laser system | Ilooda Co,., Ltd. | GEX | Class II | |
| K231336 | T2 Biothreat Panel | T2biosystems, Inc. | QVR | Class II | |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | BSO | Class II | |
| K231235 | LW UCLA Abutment | Ossvis Co., Ltd. | NHA | Class II | |
| K230974 | NIDO™ Pedicle Screw System | Kalitec Medical, LLC | NKB | Class II | |
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical, Inc. | HWC | Class II | |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | FED | Class II | |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | Ambu A/S | FDF | Class II | |
| K230066 | Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co., Ltd. | IYN | Class II | |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Medical | CHL | Class II | |
| K223812 | Sensis Vibe (VD15) | Siemens Medical Solutions USA, Inc. | DQK | Class II | |
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter | Medsource International, LLC | FOZ | Class II | |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics GmbH | JZO | Class II | |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | Poonglim Pharmatech, Inc. | QNQ | Class II | |
| K220972 | Access Thyroglobulin | Siemens Healthcare Diagnostics Inc. | MSW | Class II | |
| K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc | GYB | Class II | |
| K232827 | LightForce Orthodontic System | LightForce Orthodontics | NJM | Class II | |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | OAS | Class II | |
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine | Baxter Healthcare Corporation | KDI | Class II | |
| K232462 | ThermPix Thermovisual Camera | USA Therm Inc. | LHQ | Class I | |
| K232189 | OrionXR | Hoth Intelligence, Inc. | LLZ | Class II | |
| K232146 | Anovo Pedestal | Momentis Surgical Ltd. | QNM | Class II | |
| K232124 | IPL Hair Removal, Model: W-1095, W-1098 | Shenzhen Wochuan Electronic Co., Ltd. | OHT | Class II | |
| K231576 | cNeuro cPET | Combinostics | KPS | Class II | |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | MMK | Class II | |
| K231353 | AccuCTP Pro | ArteryFlow Technology Co., Ltd. | LLZ | Class II | |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation, LLC | HTY | Class II | |
| K231079 | LW Retraction Cap | Ossvis Co., Ltd. | NHA | Class II | |
| K231030 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | MQV | Class II | |
| K230987 | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | BZR | Class II | |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | FMI | Class II | |
| K230775 | SOFIA EX Intracranial Support Catheter | Terumo Cardiovascular Systems Corporation | QJP | Class II | |
| K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd | GAW | Class II | |
| K230526 | TEA Device | Transtimulation Research Inc | QHH | Class II | |
| K230237 | Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | MQC | Unclassified | |
| K230167 | Back 4 | Swims America Corp | IPF | Class II | |
| K230108 | Straumann® BLC and TLC Implants | Straumann USA, LLC | DZE | Class II | |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy-America, Inc. | HIH | Class II |