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 |
|---|---|---|---|---|---|
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | LZO | Class II | |
| K244044 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | QZX | Class II | |
| K244030 | Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd | BWK | Unclassified | |
| K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. | QQC | Class II | |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | ConvaTec Limited | KNT | Class II | |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | JBQ | Class II | |
| K242022 | Access Toxo IgG | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | KCT | Class II | |
| K234067 | ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) | Medphoton GmbH | OWB | Class II | |
| K233953 | Makani Science™ Respiration Monitoring System | Makani Science, Inc. | BZQ | Class II | |
| DEN240020 | Visby Medical Women's Sexual Health Test | Visby Medical, Inc. | SEA | Class II | |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Medtronic, Inc. | DQY | Class II | |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | QOG | Class II | |
| K250092 | HC Biologics Osteopoint Spinal Fixation System | HC Biologics LLC | NKB | Class II | |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) | Access Vascular, Inc | FOZ | Class II | |
| K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences LLC | DYB | Class II | |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | restor3d, Inc. | MBH | Class II | |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | Scivita Medical Technology Co., Ltd. | FGB | Class II | |
| K243426 | Nurochek-Pro System | Headsafe Mfg Pty Ltd | PIW | Class II | |
| K243038 | Salix Central | Artrya | QIH | Class II | |
| K242919 | V5med Lung AI | V5med, Inc. | OEB | Class II | |
| K242745 | AI-Rad Companion Organs RT | Siemens Healthcare GmbH | QKB | Class II | |
| K242201 | HyperSuture White/Green Extension Line | Threadstone LLC | GAT | Class II | |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K241862 | Levina Pelvic Floor Muscle Stimulator (RS-48) | Zmi Electronics Ltd. | KPI | Class II | |
| K241785 | StarFormer (M008-3T) | Fotona d.o.o. | QPL | Class II | |
| K250542 | AC3™ Range™ Intra-Aortic Balloon Pump | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K250134 | Power Wheelchair (YH-E6011,YH-E6013A) | Ningbo Youhuan Automation Technology Co., Ltd. | ITI | Class II | |
| K244003 | Electrically powered wheelchair | Kunshan Hi-Fortune Health Products Co., Ltd. | ITI | Class II | |
| K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex GmbH | HRS | Class II | |
| K243891 | EarliPoint System | Earlitec Diagnostics | QPF | Class II | |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge to Life Ltd | KDN | Class II | |
| K243831 | Rayvolve LN | AZmed | MYN | Class II | |
| K242669 | SnapshotGLO (KB100) | Kent Imaging Inc | QJF | Class II | |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | KNS | Class II | |
| K240189 | NM-01/CPT neurometer (NM-01/CPT) | Mde Orvosbiológiai Kutató, Fejleszto | JXE | Class II | |
| K250668 | Aventus Thrombectomy System (IM-2100) | Inquis Medical, Inc. | QEW | Class II | |
| K250225 | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical Inc. | PPN | Class II | |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis, Inc | OVD | Class II | |
| K250182 | Innovasis Navigation Instruments | Innovasis, Inc | OLO | Class II | |
| K250125 | Lmnt O2 | Xplr, Ltd. | OHS | Class II | |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) | Control Medical Technology, Inc. / dba Ventiv Scientific | QEZ | Class II | |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | JWH | Class II | |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Corp. | LFL | Unclassified | |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine, Inc. | MRW | Unclassified | |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular Inc | NEU | Class II | |
| K243525 | SonoTAP and SonoTAP II | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. | EXQ | Class II | |
| K242893 | VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System | Luma Vision Limited | OBJ | Class II |