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 |
|---|---|---|---|---|---|
| K251196 | Composite Orthodontic Brackets and Buttons | EC Certification Service GmbH | DYW | Class II | |
| K250176 | DAND Dental Implant System | D.A.N.D Metal Industries North Ltd | DZE | Class II | |
| K243875 | Spectricept Skin and Wound Cleanser | Spectrum Antimicrobials, Inc. | FRO | Unclassified | |
| K243651 | VersaViewer | GE Medical Systems SCS | LLZ | Class II | |
| K243508 | Wearable breast pump (model S12A) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | MOF | Class II | |
| K242254 | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | Class II | |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | PKL | Class II | |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer GmbH | LZO | Class II | |
| K250481 | Extension Feeding Set with ENFit™ Connectors | SKY Medical, A.S. | PIF | Class II | |
| K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution | Technoflex SAS | KPE | Class II | |
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | ONE | Class II | |
| K250146 | SofWave System | Sofwave Medical Ltd. | NGX | Class II | |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | MQB | Class II | |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation | PEN | Class II | |
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | DCK | Class II | |
| K241996 | Ultra 1040 | Ecoray Co., Ltd. | IZL | Class II | |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 System | Sekisui Diagnostics, LLC | PSZ | Class II | |
| K240775 | PeriBeam® Pericardial Membrane | Tamabio Co.,Ltd. | DXZ | Class II | |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | FMI | Class II | |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | |
| K250829 | Lacevo Wearable Breast Pump (Model S70) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | PLQ | Class II | |
| K250455 | FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) | Fluoptics SAS (A Getinge Group Company) | QDG | Class II | |
| K250270 | Luja Set | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K243878 | Clarus (700) | Carl Zeiss Meditec Inc | QER | Class II | |
| K243750 | SimpleStitch Suturing System | Envision Endoscopy Inc. | OCW | Class II | |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | OBP | Class II | |
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | QCI | Class II | |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS | Class II | |
| K242992 | RayCare (2024A SP1) | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | IMDS Operations B.V. | DQY | Class II | |
| K242129 | VitalRhythm | VitalConnect, Inc. | DQK | Class II | |
| K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus | Benq Materials Corporation | LPL | Class II | |
| DEN240062 | Minder System | Epi-Minder Pty, Ltd. | SEM | Class II | |
| K250850 | Nanox.ARC X | Nano-X Imaging Ltd | IZF | Class II | |
| K250809 | Stellar M22 | Lumenis Ltd | GEX | Class II | |
| K243853 | Clarius Prostate AI | Clarius Mobile Health Corp | QIH | Class II | |
| K243513 | Dcm (Pw-Dcm) | Pneumowave, Ltd. | LEL | Class II | |
| K242806 | Medyssey Navigation System | Medyssey Co., Ltd. | OLO | Class II | |
| K242647 | MySegmenter (v2.0.0) | Mysegmenter Technologies, Inc. | LLZ | Class II | |
| K242500 | Laralab | Laralab GmbH | QIH | Class II | |
| K241733 | Hebe (Np0000763) | Novasonix Technology S.L. | PBX | Class II | |
| K250833 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | NPL | Class II | |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set | Boston Scientific Corporation | FAD | Class II | |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | Anhui Deepblue Medical Technological Co., Ltd. | NGL | Class II | |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta Ltd. | JAK | Class II | |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | Stryker Corp. | GEI | Class II | |
| K250212 | LapBox Power Tissue Containment System | Ark Surgical | PMU | Class II | |
| K243055 | Préime DermaFacial Collagen+ | EMA Aesthetics, Ltd. | PBX | Class II |