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 |
|---|---|---|---|---|---|
| K994375 | Horizon Light | B.Braun Medical, Inc. | FRN | Class II | |
| K994323 | Kawasumi Laboratories Philebotomy Set | Kawasumi Laboratories Co., Ltd. | LHI | Class II | |
| K993894 | Lifecore Single Tooth Abutment System | Lifecore Biomedical LLC | DZE | Class II | |
| K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | FOZ | Class II | |
| K992933 | Lemaitre Irrigation Catheter | Vascutech, Inc. | DXE | Class II | |
| K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath | Cardiac Pathways Corp. | DRF | Class II | |
| K991271 | Oocyte Aspiration Needle | Casmed UK | MQE | Class II | |
| K990831 | Superguard Safety Syringe | U.S. Safety Syringes Co., Inc. | MEG | Class II | |
| K990718 | Orion Series Surgical Laser System (Sl Seriesq-Switched Nd:yag Configuration) | Laserscope | GEX | Class II | |
| K982558 | Bd Preefile Normal Saline Flush Syringe Flush Syringe | Bd/Preefil | FOZ | Class II | |
| K000657 | Luer Access Universal Vial Adapter | Baxter Healthcare Corporation | FMI | Class II | |
| K000497 | Voyager/viper Wheelchair | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | |
| K994428 | E7512 Premie Rem Polyhesive II Patient Return Electrode | Medtronic, Inc. | GEI | Class II | |
| K994378 | Airis II | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K994167 | Code Ac: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera with Coincidence Option (Code) | GE Medical Systems F.I. Haifa | KPS | Class II | |
| K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | BZD | Class II | |
| K993456 | Sas Strep a Test | SA Scientific, Ltd | GTY | Class I | |
| K992386 | Allon 2000 | Mtre Advanced Technology, Ltd. | DWJ | Class II | |
| K991470 | Medi-Cult Acidified Tyrodes Solution- Medium; Internal Catalog Numbers (1060) | Medicult A/S | MQL | Class II | |
| K000608 | Suction Vascular Stapler and Implantable Staple System | Std Mfg., Inc. | GDW | Class II | |
| K000513 | Modification to Ebi Spinelink Anterior Cervical Spinal System | Ebi, LLC | KWQ | Class II | |
| K000447 | Quickscreen Methamphetamine Test, Models 9045, 9046, Quickscreen Pro Multi Drug Screening Test, Model 9225 | Phamatech Inc. | LAF | Class II | |
| K000425 | Isobar Spinal System | Encore Orthopedics, Inc. | MNI | Class II | |
| K000397 | Speedband Superview Multiple Band Ligator, Models 4225, 4228; Injection Speedband Superview Multiple Band Ligator, Model | Boston Scientific Corporation | FHN | Class II | |
| K000296 | Starion Cautery Hook | Microline Surgical, Inc | GEI | Class II | |
| K000270 | Elecsys Cortisol Test System | Roche Diagnostics GmbH | JJY | Class I | |
| K000250 | Cautery Forceps with Footswitch | Microline Surgical, Inc | GEI | Class II | |
| K994363 | Instruments for Minimally Invasive Spinal Surgery (Miss) | Richard Wolf Medical Instruments Corp. | HRX | Class II | |
| K994299 | Art-P3, Model P3-1-Art-A1 | Bonart Co. Ltd. | ELC | Class II | |
| K994203 | Art-M3 25K, Model M3-1-Art2-A1; Art-M3 30K, Model M3-1-Art3-A1 | Bonart Co. Ltd. | ELC | Class II | |
| K994152 | The Ligament Anchor Soft Screw | Corin USA | HWC | Class II | |
| K994142 | Grass Ts3201/6401 EEG Amplifier System | Grass Instrument Co. | OLV | Class II | |
| K994128 | Scorpio Total Stablizer (Ts) Total Knee System | Howmedica Osteonics Corp | JWH | Class II | |
| K992908 | Q-Tel Telemetry System V. 6.0 (St) | Quinton, Inc. | DSI | Class II | |
| K991798 | Acme Medical Aesthetic Nd:yag Laser | Altus Medical, Inc. | GEX | Class II | |
| K000482 | Modification to Autoject Mini | Owen Mumford Limited | KZH | Class II | |
| K000384 | Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex | CooperVision, Inc. | LPL | Class II | |
| K994429 | Venusa, Ltd. Extension Set with Filter | Venusa Ltd. | FPA | Class II | |
| K994374 | Soaker Catheter | Halyard Health | FRN | Class II | |
| K994348 | Ksea Scb-Rui | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K994341 | Fibrinogen Calibrator Kit | Siemens Healthcare Diagnostics Inc. | GFX | Class II | |
| K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb Incorporated | LPL | Class II | |
| K994057 | Slendair 4000 Compression System | Medical Compression Systems (Dbn), Ltd. | IRP | Class II | |
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen Receptor | Dako Corp. | MYA | Class II | |
| K993604 | Endoscopic Anti Fog Device | Mectra Labs, Inc. | OCT | Class II | |
| K993557 | Autostat II Rheumatoid Factor Iga Elisa | Cogent Diagnotics, Ltd. | DHR | Class II | |
| K993081 | Io-Drive | Spectramed, LLC | EGJ | Class II | |
| K000602 | Protege Wheelchair | Otto Bock Orthopedic Industry, Inc. | IOR | Class I | |
| K000200 | Cortek Uretheroscope | Cortek Endoscopy, Inc. | FGB | Class II | |
| K000197 | Cortek Cystoscope | Cortek Endoscopy, Inc. | FAJ | Class II |