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 |
|---|---|---|---|---|---|
| K250882 | Sansa Hsat | Huxley Medical | MNR | Class II | |
| K250618 | Medi Lift Essential Eye Mask | YA-Man Ltd. | NFO | Class II | |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc | JDW | Class II | |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter | Volcano Corporation (dba Philips Image Guided Therapy Device | OBJ | Class II | |
| K253300 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | HRS | Class II | |
| K252742 | Navigated Instruments | Tyber Medical | OLO | Class II | |
| K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | LLZ | Class II | |
| K252376 | Yomi S Robotic System | Neocis Inc. | PLV | Class II | |
| K252351 | UniSpace® TPLIF Cage | CG MedTech Co., Ltd. | MAX | Class II | |
| K252165 | Zirconomer P | Shofu Dental Corp. | EMA | Class II | |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell Inc. | JOW | Class II | |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch | Baylis Medical Technologies Inc. | GEI | Class II | |
| K252630 | Electric Breast Pump (HL-3060, F5113) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd | HGX | Class II | |
| K252629 | Electric Breast Pump (HL-3058, F5112) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd | HGX | Class II | |
| K252467 | Disposable Vinyl Examination Gloves | Viet Phu Trade and Import Export Co., Ltd | LYZ | Class I | |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd | OHS | Class II | |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors | SAN | Class II | |
| K251824 | Patriot Duo | Patriot Laser, LLC | GEX | Class II | |
| K251331 | Blood Pressure Monitor (B73, BE23T) | Shenzhen Jamr Technology Co., Ltd | DXN | Class II | |
| K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging Inc | QIH | Class II | |
| K250520 | OsteoCentric Navigated Instruments System | OsteoCentric Technologies,Inc | OLO | Class II | |
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | GWO | Class II | |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine Inc | MAX | Class II | |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics GmbH | GJS | Class II | |
| K253150 | Cryon-X Cold Compression | JKH Health Co., Ltd. | IRP | Class II | |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA Inc | NKG | Class II | |
| K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production | FTL | Class II | |
| K253106 | AngioVac Cannula | Boston Scientific Corporation | DWF | Class II | |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | NKB | Class II | |
| K252646 | Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) | Olympus Medical Systems Corp. | FCG | Class II | |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | DQK | Class II | |
| K252357 | Glucose2 | Abbott Ireland | CFR | Class II | |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | DQK | Class II | |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., dba Stryker Orthopaedics | MBH | Class II | |
| K251974 | Arctic Sun Temperature Management System (Model 5000) | Medivance Inc. | DWJ | Class II | |
| K251827 | Azurion R3.1 | Philips North America LLC | OWB | Class II | |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte, Ltd. | LRK | Class II | |
| K251710 | Mobile X-ray unit (!M1) | Solutions for Tomorrow AB | IZL | Class II | |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc. | QJP | Class II | |
| K251312 | Vesalio Peripheral System | Vesalio | QEZ | Class II | |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | QIH | Class II | |
| K250904 | Atalante X | Wandercraft | PHL | Class II | |
| K250696 | AccuCheck | Manteia Technologies Co.,Ltd. | IYE | Class II | |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global Inc. | MUH | Class II | |
| K250345 | Medline Bag Decanter | MEDLINE INDUSTRIES, LP - Northfield | LHI | Class II | |
| K253226 | UV5000W Handle | Uroviu Corporation | FAJ | Class II | |
| K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | NXC | Class II | |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd | GEX | Class II |