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 |
|---|---|---|---|---|---|
| K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes | CooperSurgical, Inc. | HHW | Class II | |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System | Canon Medical Systems Corporation | IYN | Class II | |
| K253291 | Excelsior System | Blue Ocean Global | KTT | Class II | |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K252537 | Rusch SoftSimplastic Foley Catheters | Teleflex Medical Sdn. Bhd. | EZL | Class II | |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) | Scivita Medical Technology Co., Ltd. | FBN | Class II | |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc | QEY | Class II | |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Eastman Kodak Company | KPR | Class II | |
| K254114 | Baylis Connector Cable | Baylis Medical Technologies Inc. | DSA | Class II | |
| K254085 | CARTO™ 3 EP Navigation System V9.0 with PIU Plus | Biosense Webster Inc | DQK | Class II | |
| K253363 | NeuroSpan Bridge | Auxilium Biotechnologies, Inc. | JXI | Class II | |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | LOX | Class II | |
| K254186 | Azurion R3.1 | Philips North America LLC | OWB | Class II | |
| K254126 | Natrelle 133S Tissue Expanders | AbbVie Inc | LCJ | Unclassified | |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | NAY | Class II | |
| K253408 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International Inc | DJG | Class II | |
| K252960 | SOLIUS PRO UVB Light Panel | Solius Labs, Inc. | SGZ | Class II | |
| K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg | Hycor Biomedical | DHB | Class II | |
| K252767 | actiTENS mini | Sublimed | GZJ | Class II | |
| K252634 | Imagine® Enterprise Suite | Softlink International Private Limited | QIH | Class II | |
| K252297 | Toro 88 Superbore Catheter | Toro Neurovascular, Inc. | QJP | Class II | |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | ODP | Class II | |
| K251934 | qXR-Detect | Qure.ai Technologies Inc | MYN | Class II | |
| K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | Unclassified | |
| K251790 | SeptAlign | Spirair, Inc | NHB | Class II | |
| K251744 | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic, Inc. | DTM | Class II | |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K251721 | Xpert GI Panel | Cepheid | PCH | Class II | |
| K251714 | Ion-C | Surgentec LLC | MRW | Unclassified | |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Ltd. | BTT | Class II | |
| K251367 | OptoMonitor 3 | Opsens Inc. | DXO | Class II | |
| K251353 | Eyer 2 | Phelcom Technologies | HKI | Class II | |
| K251341 | VITAL Tubing Sets for Hemodialysis | Vital Healthcare Sdn. Bhd. | FJK | Class II | |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | GKZ | Class II | |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | MWI | Class II | |
| DEN250005 | Sana Device | Sana Health, Inc. | QYN | Class I | |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | ODP | Class II | |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | Trimed Inc | HRS | Class II | |
| K253925 | Aventus Thrombectomy System | Inquis Medical, Inc. | QEZ | Class II | |
| K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | Medtronic, Inc. | QFG | Class II | |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics Inc. | LZO | Class II | |
| K253023 | BIOGRAPH One | Siemens Healthineers AG | OUO | Class II | |
| K252934 | Diagnocat | Dgnct LLC | MYN | Class II | |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical, LP | PHX | Class II | |
| K252516 | N22 EZ Glenosphere | SHOULDER INNOVATIONS, Inc | PHX | Class II | |
| K252283 | Nano-Check Influenza A+B Test | Nano-Ditech Corporation | PSZ | Class II | |
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) | Elekta Solutions AB | IYE | Class II | |
| K251961 | SDS Growing Rod | Baat Medical Products B.V. | PGM | Class II |