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 |
|---|---|---|---|---|---|
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW | Class II | |
| K201260 | Dermal Cooling System | R2 Technologies, Inc. | GEH | Class II | |
| K201051 | Straumann BoneCeramic | Straumann USA, LLC | LYC | Class II | |
| K200569 | RayStation | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | OVE | Class II | |
| DEN200002 | Tangible Boost | TANGIBLE SCIENCE Inc | QMM | Class II | |
| K202569 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy | HWC | Class II | |
| K202479 | IBS Implant System | Innobiosurg Co., Ltd. | DZE | Class II | |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | Synthes (USA) Products LLC | HSB | Class II | |
| K201208 | Halo AF Detection System | Livmor | DXH | Class II | |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb Incorporated | MRC | Class II | |
| K200414 | Pulse Oximeter | Shenzhen Aeon Technology Co.,Ltd | DQA | Class II | |
| K193276 | Nerve and Muscle Stimulator | Shenzhen XFT Medical Limited | GZI | Class II | |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal | Alcon Laboratories | MVN | Class II | |
| K202210 | Vantage Orian 1.5T, MRT-1550, V6.0 | Canon Medical Systems Corporation | LNH | Class II | |
| K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K200987 | LTJ Screws and Washer | Azurmeds, Inc. | HWC | Class II | |
| K200843 | Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs | O&M Halyard, Inc. | LZA | Class I | |
| K200123 | Accessories for the SixFix® Hexapod Fixator | Arrowhead de LLC | KTT | Class II | |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Bioland Technology Ltd. | DXN | Class II | |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | MEDLINE INDUSTRIES, LP - Northfield | IPF | Class II | |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty Limited | MEH | Class II | |
| K192814 | Pounce Thrombus Retrieval System | Surmodics, Inc. | QEW | Class II | |
| K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K201350 | Corvus | Best Nomos | MUJ | Class II | |
| K200603 | AAA Model | Philips North America LLC | LLZ | Class II | |
| K201532 | B&J DVT Calf/Thigh Garments, Models 801/830 Series | B&J Manufacturing, Ltd. | JOW | Class II | |
| K202463 | Disposable Surgical Mask | Unisources Group, LLC | FXX | Class II | |
| K202399 | OrthoButton FL | Riverpoint Medical, LLC | MBI | Class II | |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corp. | KNW | Class II | |
| K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) | Medacta International SA | JWH | Class II | |
| K201992 | Caption Guidance | Caption Health | QJU | Class II | |
| K201746 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies Ltd. | MHX | Class II | |
| K201673 | SMS Cementless Stem | Medacta International SA | LZO | Class II | |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | Chalice Medical Ltd | DTZ | Class II | |
| K201547 | B&J DVT Foot Garments, Models 820 Series | B&J Manufacturing, Ltd. | JOW | Class II | |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine | OUR | Class II | |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | LZC | Class I | |
| K201224 | Electrosurgical Generator and Accessories | Medrange Corporation | GEI | Class II | |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | Fresenius Medical Care Renal Therapies Group, LLC | KOC | Class II | |
| K201073 | Seaspine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | |
| K201013 | Optixon 1-Day | Optixon, Inc. | LPL | Class II | |
| K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Healthcare | LLZ | Class II | |
| K200174 | Dia-Root Bio Mta | Diadent Group International | KIF | Class II | |
| K193368 | Smart Correction System | Wishbone Medical, Inc. | KTT | Class II | |
| K192890 | SentEP | Sentiar, Inc. | LLZ | Class II | |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | Synthes (USA) Products LLC | GXN | Class II | |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets | Abbott Medical | FPA | Class II | |
| K190798 | LaborView™ LV1000 Wireless Electrode System | Obmedical Company | OSP | Class II |