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 |
|---|---|---|---|---|---|
| K230640 | Affinity Fusion™ Oxygenator System | Medtronic, Inc. | DTZ | Class II | |
| K230341 | Acrifix | Deltamed GmbH | EBI | Class II | |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | In2Bones SAS | HSN | Class II | |
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P dba Enovis | JWH | Class II | |
| K230097 | IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | Shenzhen BSX Technology Electronics Co.,Ltd | OHT | Class II | |
| K230069 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | NHA | Class II | |
| K223774 | Contour ProtégéAI | MIM Software Inc | QKB | Class II | |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | GE Healthcare Finland Oy | MHX | Class II | |
| K223458 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | FMI | Class II | |
| K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K222023 | RayFlow | Hexacath | DQY | Class II | |
| K230689 | T-FIX™ 3DSI Joint Fusion System | Cutting Edge Spine | OUR | Class II | |
| K230336 | CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) | Light Tree Ventures Europe B.V. | OAP | Class II | |
| K230107 | Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 | Kam Yuen Plastic Products Ltd. | OHT | Class II | |
| K230035 | BioSci™ Disposable Virus Sampling Tubes | Shenzhen Dakewe Bio-Engineering Co., Ltd. | JSM | Class I | |
| K230033 | Da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System | Medtronic, Inc. | MXD | Class II | |
| K223310 | Antimicrobial Silicone PHMB Foam Wound Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K223256 | Optimos™ Cystotome | Taewoong Medical Co., Ltd. | KNS | Class II | |
| K222677 | Intermittent nelaton catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | EZD | Class II | |
| K222012 | Faq 101 | Foreo Inc | PAY | Class II | |
| K221537 | Nightwear Aligners | Smylio | NXC | Class II | |
| K221493 | MicroScan Prompt Inoculation System-D | Siemens Healthcare Diagnostics Inc. | LIE | Class II | |
| K221118 | CO2 Mainstream Sensor | Draegerwerk AG & Co. KGaA | CCK | Class II | |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | LIT | Class II | |
| K211556 | N2 | Megagen Implant Co., Ltd. | EIA | Class I | |
| K230385 | Ballancer Platinum (1222) | Mego Afek | IRP | Class II | |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics Inc. | OBP | Class II | |
| K220142 | BRM Digitalis Spacer | BRM Extremities SRL | KYJ | Class II | |
| K213584 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC. | QLZ | Class II | |
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | Cardinal Health200, LLC | JOW | Class II | |
| K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty, Ltd. | QAS | Class II | |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | KNW | Class II | |
| K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | FBK | Class II | |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) | Mawi DNA Technologies | QBD | Class II | |
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical | NAM | Class II | |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Co. Ltd. | EIA | Class I | |
| K222370 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | DSA | Class II | |
| K230568 | FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | CCL | Class II | |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K230356 | Aspirex™ Thrombectomy System | C.R. Bard Inc | QEW | Class II | |
| K230312 | Iris AirShuttle™ | Qfix | IYE | Class II | |
| K230274 | Medical Diode Laser (M2) | Wuhan Pioon Technology Co.,Ltd. | GEX | Class II | |
| K230238 | BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx | Shenzhen Bioeasy Biotechnology Co., Ltd. | DJG | Class II | |
| K230041 | Spectrum IQ Infusion System with Dose IQ Safety Software | Baxter Healthcare Corporation | FRN | Class II | |
| K230022 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | FRN | Class II | |
| K230021 | IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 | Shenzhen Yangyi Technology., Ltd. | OHT | Class II |