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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K000607 | Solo-Care Brand Hard Solution | Alcon Laboratories | MRC | Class II | |
| K000510 | Art-M1, Model M1-1-Art-A1 | Bonart Co. Ltd. | ELC | Class II | |
| K000503 | Medart 520 Cooling System | MEDART ApS | GEX | Class II | |
| K000493 | Stryker Irrigation Tube Set | Stryker Corp. | GCJ | Class II | |
| K000399 | Stc Pcp Intercept Micro-Plate Eia, Model 11541 | OraSure Technologies, Inc. | LCM | Unclassified | |
| K000179 | Nuzone Nitrile Surgical Gloves Powder Free | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K000078 | Jetlite 4000 | J. Morita USA, Inc. | EBZ | Class II | |
| K992823 | Spirovit Sp-2, Pneumocheck II | Schiller, AG | BZG | Class II | |
| K992192 | Airpilotmask, Model Tms-900 | Tiara Medical Systems, Inc. | BZD | Class II | |
| K992178 | Balloon for Ultrasonic Endoscopes | N.M. Beale Co., Inc. | ITX | Class II | |
| K001368 | Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter | Carmel Pharma AB. | LHI | Class II | |
| K001267 | Ge System Five | GE Healthcare | IYN | Class II | |
| K001208 | Espirt | Respironics, Inc. | CBK | Class II | |
| K001198 | Datascope Nitinol Catheter Guide Wire (145 Cm), Datascope Nitinol Catheter Guide Wire (175 Cm), Datascope Nitinol Cathet | Datascope Corp. | DQX | Class II | |
| K001171 | Delta 16 Tact | Instrumentarium Imaging, Inc. | IZH | Class II | |
| K000950 | Embryo Transfer Catheter Set, Model 320200 and 320201 | Labotect Labor-Technik Gottingen | MQF | Class II | |
| K000948 | Olympus Endoscopic Flushing Pump Model Ofp-1 | KEYMED (Medical & Industrial Equipment) Ltd | FEQ | Class II | |
| K000915 | Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-Pp-9, 16-Pp-5.75 | CooperSurgical, Inc. | MQK | Class II | |
| K000905 | Urethrotome 8667.Xxx and 8670.Xxx | Richard Wolf Medical Instruments Corp. | EZO | Class II | |
| K000819 | Philips CT Secura Mv | Philips North America LLC | JAK | Class II | |
| K000630 | Models Priam (Family of Devices) Digital Imaging System | Hopkins Imaging Systems, Inc. | LLZ | Class II | |
| K000485 | Hydro2, Hs-75 | Innovision, Inc. | HQD | Class II | |
| K000281 | Wallstent Enternal Prosthesis | Boston Scientific Corporation | MQR | Class II | |
| K000162 | Metriscan Bone Density System | Alara, Inc. | KGI | Class II | |
| K994362 | Headlamp Hl2000. | Angiolaz, Inc. | FSR | Class II | |
| K993815 | Uni-Laser 430 | MEDART ApS | GEX | Class II | |
| K992819 | Wand Plus | Spintech, Inc. | EJI | Class II | |
| K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor | Pulsion Medical Systems AG | KRB | Class II | |
| K001272 | Xia Spine System | Howmedica Osteonics Corp | KWQ | Class II | |
| K001197 | Cocaine Metabolite Intercept Micro-Plate Eia | OraSure Technologies, Inc. | DIO | Class II | |
| K001196 | Jel Bios 90 (Code Name Rd-2401) | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K001145 | Sysmex Automated Coagulation Analyzer, Model Ca-6000 | Siemens Healthcare Diagnostics Inc. | GKP | Class II | |
| K001055 | Model 4300 Psarray EEG Electrode Set | Physiometrix, Inc. | GXY | Class II | |
| K001030 | Respiratory Belt Sensor, Model 6000S; Limb Movement Sensor, Model 3000S | Dymedix, Inc. | BZQ | Class II | |
| K000965 | Multi-Axial Cross (Mac) Connector | Howmedica Osteonics Corp | MNI | Class II | |
| K000710 | Md 10, Sem, Sm 12, Cbm | Nouvag AG | EFB | Class I | |
| K000706 | Datex-Ohmeda Aestiva/5 with 7100 Ventilator | GE Healthcare | BSZ | Class II | |
| K000694 | Pectofix Dynamic Sternal Fixation System (Dsf) | Pectofix, Inc. | JDQ | Class II | |
| K000658 | Ers Radial Head Replacement | Depuy Orthopaedics Inc. | KWI | Class II | |
| K000636 | Stryker Trauma Plating System | Howmedica Osteonics Corp | HRS | Class II | |
| K000590 | Lateral Pivot Insert | Encore Orthopedics, Inc. | JWH | Class II | |
| K000189 | Pq1 | Ultradent Products Inc. | KLE | Class II | |
| K991031 | Colorado II Spinal System | Sofamor Danek USA,Inc. | MNH | Class II | |
| K001139 | Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M | Biosense Webster Inc | DYB | Class II | |
| K000521 | Keystone Hip | Encore Orthopedics, Inc. | LPH | Class II | |
| K000514 | Rumbar Drainage System | Phoenix Biomedical Corp. | JXG | Class II | |
| K000472 | Posi-Link | Abbott Medical | FPA | Class II | |
| K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240 | Nichols Institute Diagnostics | MSW | Class II | |
| K991472 | Medi-Cult Embryo Freezing Medium Internal Cataglog Numbers 1079 | Medicult A/S | MQL | Class II | |
| K991471 | Medi-Cult Blastocyst Freezing & Thawing Packs, Internal Catalog Numbers (1012, 1015) | Medicult A/S | MQL | Class II |