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 |
|---|---|---|---|---|---|
| K242759 | Geister K-Rex rongeurs | Geister Medizin Technik GmbH | HAE | Class II | |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | EMPATICA S.r.l. | MWI | Class II | |
| K242431 | Omnia Medical PsiF DNA™ System | Omnia Medical | OUR | Class II | |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | Quanta System Inc. | GEX | Class II | |
| K251456 | BrightHeart View Classifier | Brightheart | QIH | Class II | |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | EIH | Class II | |
| K250800 | UroNav 4 | Philips DS North America LLC | LLZ | Class II | |
| K250701 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) | Olympus Medical Systems Corp. | FDT | Class II | |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Abbott Medical | FPA | Class II | |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Medline ReNewal | OWQ | Class II | |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK) | Shenzhen Idea Light Limited | OAP | Class II | |
| K243703 | TechLive | Deephealth | LLZ | Class II | |
| K243667 | Sonic DL | GE Healthcare | LNH | Class II | |
| K243639 | Portare System (FA-001) | Grumpy Innovation Inc | EOB | Class II | |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC. | MSX | Class II | |
| K242744 | Trinity EVO Acetabular Shell | Corin USA | LPH | Class II | |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | CAW | Class II | |
| K242704 | Synchrony (20-3000) | Synapse Biomedical Inc | GZI | Class II | |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank Mounts | Medtronic Navigation, Inc | OLO | Class II | |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical Oy | HBE | Class II | |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K251216 | 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line | Barbaras Development, Inc. | CCK | Class II | |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co.,Ltd. | JKA | Class II | |
| K250879 | Paradigm System | Proprio | OLO | Class II | |
| K250804 | Id Light Cure System | ID Korea Co., Ltd. | EBD | Class II | |
| K250749 | PhysCade System | Physcade, Inc. | DQK | Class II | |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | Scottcare Corporation | DRG | Class II | |
| K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corp. | EOQ | Class II | |
| K243843 | Tendon Protect (50242) | Kerecis Limited | OWY | Class II | |
| K243810 | TraumaCad Neo (1.1) | Brainlab, Inc. | QIH | Class II | |
| K243499 | NG-Test® CTX-M MULTI | NG Biotech | PTJ | Class II | |
| K243368 | Montblanc Plate System | Medifield Medical Co., Ltd. | HRS | Class II | |
| K242712 | LubriZenzs | Sk Zen, LLC | NUC | Class II | |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | IPF | Class II | |
| K240788 | Ultrasound Stimulator | JKH Health Co., Ltd. | IMI | Class II | |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | PENTAX of America, Inc. | PEA | Class II | |
| K251035 | DISINTEK™ PA Test Strips | Serim Research Corp. | JOJ | Class II | |
| K250682 | BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K250657 | gi2000 Electrosurgical Generator | Cintron Medical Corporation | GEI | Class II | |
| K250598 | Endoform Reconstructive Template - PLGA | AROA Biosurgery Inc. | FTM | Class II | |
| K250529 | Globe Introducer (601-01001) | KARDIUM Inc. | DRA | Class II | |
| K250001 | Patriot SI Implant System | Spinal Simplicity, LLC | OUR | Class II | |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | NRY | Class II | |
| K243796 | GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] | Glove One, LLC | LZA | Class I | |
| K243382 | RZ Resectoscope System | RZ Medizintechnik GmbH | HIH | Class II | |
| K243205 | Evac | Phasor Health, LLC | JXG | Class II | |
| K242897 | Partial Flex | Clemde S.A. de C.V. | EBI | Class II | |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | MAX | Class II | |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | JPA | Class II | |
| K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop | Science & Bio Materials, S.B.M. SAS | MBI | Class II |