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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151921 | Sterispine Ps | Safe Orthopaedics | NKB | Class II | |
| K151744 | Passeo-18 Peripheral Dilation Catheter | BIOTRONIK AG | LIT | Class II | |
| K151584 | AttraX Putty | Progentix Orthobiology BV | MQV | Class II | |
| K151490 | Prettau Anterior T0 | Zirkonzahn SRL | EIH | Class II | |
| K151352 | CONCORDE Bullet Spinal System | Medos International SARL | MAX | Class II | |
| K151169 | OsteoReady ZircoSeal Abutments | Osteoready, LLC | NHA | Class II | |
| K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | Medtronic, Inc. | PIF | Class II | |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | Neoss, Ltd. | NHA | Class II | |
| K150557 | Podimetrics Remote Temperature Monitoring System | Podimetrics, Inc. | OIZ | Class I | |
| K150222 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC | PLV | Class II | |
| K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | KNS | Class II | |
| K134036 | Wavetronic 5000 Digital HF Surgical Unit | Loktal Medical Electronics Ind. Com. Ltda- Epp | GEI | Class II | |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | BioFire Diagnostics, LLC | PLO | Class II | |
| K151941 | DEXIS Webview | Imaging Sciences International /Gendex/Dexis | LLZ | Class II | |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | bioMerieux, Inc. | JWY | Class II | |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large | Medela AG | OMP | Class II | |
| K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | PCU | Class II | |
| K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | IYN | Class II | |
| K151917 | ARIES System | Luminex Corporation | OOI | Class II | |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) | Luminex Corporation | PGI | Class II | |
| K151613 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | |
| K151610 | Comet Pressure Guidewire | Boston Scientific Corporation | DXO | Class II | |
| K151603 | Arcos One-piece Femoral Revision System | Zimmer GmbH | LPH | Class II | |
| K151360 | Inion Spinal Graft Containment System | Inion Oy | OJB | Class II | |
| K151266 | Physica CR Knee System | Lima Corporate S.p.A. | JWH | Class II | |
| K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | ILY | Class II | |
| K150209 | Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc | DePuy Mitek, Inc. | MAI | Class II | |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech LLC | DJR | Class II | |
| K151910 | Ultrasound Scanner System BK2300 | BK Medical ApS | IYN | Class II | |
| K151841 | Ultraviolet Sunlamps | Wolff System Technology Corp. | LEJ | Class II | |
| K151747 | Sterispine Ps | Safe Orthopaedics | NKB | Class II | |
| K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | Custom Orthopaedic Solutions, Inc. | KWS | Class II | |
| K143560 | CygneX I System | Accuthera, Inc. | IYE | Class II | |
| K143494 | ADX6000 Portable X-Ray System; iRayA6 | Dexcowin Co., Ltd. | IZL | Class II | |
| K152545 | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics GmbH | JIT | Class II | |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | LHN | Class II | |
| K151615 | TiTHON Staple with OsseoTi Technology | Biomet Manufacturing Corp | JDR | Class II | |
| K151599 | iSy Implant System | Altatec GmbH | DZE | Class II | |
| K151501 | OrthoVis Web Portal | Custom Orthopaedic Solutions, Inc. | LLZ | Class II | |
| K151408 | LOSPA IS Spinal System | Corentec Co., Ltd. | MAX | Class II | |
| K151027 | zensor system | Intelesens Limited | MHX | Class II | |
| K150892 | CorPath 200 System | Corindus, Inc. | DXX | Class II | |
| K150754 | Argos | Santec Corporation | MXK | Class II | |
| K150063 | One Step hCG Pregnancy Test | Coretests, Inc. | LCX | Class II | |
| K143655 | Sicat Optimotion | Sicat GmbH & Co. KG | MQC | Unclassified | |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | Amedica Corp. | MAX | Class II | |
| K141656 | Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System | Philosys, Inc. | NBW | Class II | |
| K152523 | JBAIDS Influenza A & B Detection Kit | U.S Army Medical Materiel Development Activity | OCC | Class II |