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 |
|---|---|---|---|---|---|
| K201352 | 3D Auto LAA | Philips Health Care | LLZ | Class II | |
| K201177 | RadGil2 | R3 X-Ray L.L.C | MOT | Unclassified | |
| K201159 | WallFlex Colonic Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II | |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corp. | QEY | Class II | |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | 23AndMe, Inc. | QDJ | Class II | |
| K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | JAQ | Class II | |
| K192845 | Sperm Freeze, Sperm Fridge | Kitazato Corporation | MQL | Class II | |
| K192597 | Cytrans Granules | GC America Inc. | LYC | Class II | |
| K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona Inc | NHA | Class II | |
| K202276 | BracePaste Band and Build LC | American Orthodontics | DYH | Class II | |
| K202068 | The AIO Solution 3.0 | Orfit Industries NV | IYE | Class II | |
| K201632 | Tomtec-Arena | TOMTEC Imaging Systems GmbH | LLZ | Class II | |
| K201518 | Route 92 Medical 088 Access System | Route 92 Medical, Head Quarters | QJP | Class II | |
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Nobio, Ltd. | EBF | Class II | |
| K200848 | Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit | Micron Medical Corporation | GZF | Class II | |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions | EBZ | Class II | |
| K200064 | OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | Surgentec LLC | MQV | Class II | |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | DYH | Class II | |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty Limited | LPH | Class II | |
| K201961 | IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical Inc. | QAD | Class II | |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.r.l. | MBB | Class II | |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | Corcym Inc. | DTZ | Class II | |
| K201444 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | |
| K201232 | Limbus Contour | Limbus AI | LLZ | Class II | |
| K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | Arthrex GmbH | PHX | Class II | |
| K200822 | Braid | Braid.Health | LLZ | Class II | |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream | Safecare Biotech(hangzhou)co.,Ltd | LCX | Class II | |
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp | JDI | Class II | |
| K193046 | Straumann® Retentive System – Novaloc TiN Abutments | Straumann USA, LLC | NHA | Class II | |
| K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | OYJ | Class II | |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | PTA | Class II | |
| K192611 | Cuffix | Biovo Technologies, Ltd. | BSK | Class II | |
| K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | GZJ | Class II | |
| K201871 | Surgical Mask | C & S Paper Yunfu Co., Ltd. | FXX | Class II | |
| K201637 | Aurora Evacuator +Coag | Rebound Therapeutics, Corporation | GEI | Class II | |
| K201248 | Syringe Holder accessory | Vapocoolshot, Inc | MLY | Unclassified | |
| K201174 | TruDi Curette | Acclarent Inc | PGW | Class II | |
| K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | Becton Dickinson & Co | ONB | Class II | |
| K201054 | SOMNOscreen plus | Somnomedics AG | OLV | Class II | |
| K200838 | Tyece OTC TENS Model | Tyece Limited | NUH | Class II | |
| K200763 | Osteo-site Vertebral Balloon | Izi Medical | HRX | Class II | |
| K200534 | VisualEyes | Interacoustics a/S | GWN | Class II | |
| K200529 | Orion | Interacoustics a/S | LXV | Unclassified | |
| K193312 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc | MBH | Class II | |
| K192620 | SNA-001 Silver Photoparticle Topical Gel | Sienna Biopharmaceuticals, Inc. | QCY | Class II | |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | MRH | Class II | |
| K201933 | ImagenSPECT 3.0 | Cardiovascular Imaging Technologies, LLC | KPS | Class II | |
| K201722 | Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | Hyperfine Research, Inc. | LNH | Class II | |
| K201623 | LION Photocoagulator | Norlase ApS | HQF | Class II | |
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice | Varian Medical Systems, Inc. | GEH | Class II |