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 |
|---|---|---|---|---|---|
| K050803 | Pediatric Cuffed and Uncuffed Et Tubes; Standard Cuffed and Uncuffed Et Tubes | Vitaid, Ltd. | BTR | Class II | |
| K050283 | Creatinine Liquicolor | Stanbio Laboratory | JFY | Class II | |
| K050266 | Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor | Stanbio Laboratory | JFM | Class II | |
| K043479 | Mc+ Partial Vbr | Ldr Spine USA | MQP | Class II | |
| K041496 | Pentatrasfu Blood Transfusion Sets | Pentaferte S.P.A | BRZ | Class II | |
| K051630 | Super View Disposable Biom Lens Set | Insight Instruments, Inc. | HJK | Class II | |
| K051608 | Star 50 Monitoring System | Larsen & Toubro Limited | MWI | Class II | |
| K051554 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | KTT | Class II | |
| K051482 | Jan Mao Wheelchair, Model Jmc612-F18epp | Jan Mao Industries Co., Ltd. | IOR | Class I | |
| K051481 | Jan Mao Wheelchair, Model Jmc611-F18epp | Jan Mao Industries Co., Ltd. | IOR | Class I | |
| K051471 | Cardioday | Getemed Medizin- und Informationstechnik AG | DQK | Class II | |
| K051448 | Modified Contact-Heat Evoked Potential Stimulator (Cheps) | Medoc Ltd. Advanced Medical Systems | NTU | Class II | |
| K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Zimmer GmbH | LZO | Class II | |
| K051408 | Intelifuse, Inc. Warm System with Stimulinks | Intelifuse, Inc. | JDR | Class II | |
| K051392 | Bti-Scan, Version 4.0 | B.T.I. Biotechnology Institute, S.L. | LLZ | Class II | |
| K051219 | Pushlock | Arthrex GmbH | MAI | Class II | |
| K051168 | Barrx Halo 360 System, Model 1100C-115A | Barrx Medical, Incorporated | GEI | Class II | |
| K051069 | Nonresorbable Centraloc Tibial Screw & Washer | Arthrotek, Inc. | MBI | Class II | |
| K051054 | Visulize Factor IX Antigen Kit | Affinity Biologicals Inc. | GGP | Class II | |
| K051050 | Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5Ml, Sebond Grip 3G, Models 644090, 644091, 640066, 644092 | Schutz-Dental GmbH | KLE | Class II | |
| K051027 | Stalif Tt | Surgicraft, Ltd. | MQP | Class II | |
| K051017 | R-X-Fix External Fixator | R-X-Fix | KTT | Class II | |
| K050953 | Air Safety Model 3000/06 Filter Hepa Reusable | Air Safety, Ltd. | CAH | Class II | |
| K050928 | Dade Thrombin Reagent | Siemens Healthcare Diagnostics Inc. | KQJ | Class II | |
| K050858 | Ascentia Heartstation ECG Management System | Heartlab, Inc. | DPS | Class II | |
| K050845 | Monocryl Plus Antibacterial Suture | Ethicon, Inc | GAM | Class II | |
| K050802 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | NAY | Class II | |
| K050799 | Triage(r) D-Dimer Calibration Verification Controls; Triage(r) D-Dimer Controls | Biosite Incorporated | GGN | Class II | |
| K050441 | Taper 2 Porous Femoral Stem | Zimmer GmbH | JDI | Class II | |
| K043349 | Open Radiotransparent Intersomatic Implant (Roi) | Ldr Spine USA | MQP | Class II | |
| K042891 | Datex-Ohmeda Oxy-Afr Sensor | GE Healthcare | NLF | Class II | |
| K051560 | Nexus Detachable Coil, Multi-Diameter Csr and Helix Super Soft Csr | Medtronic, Inc. | HCG | Class II | |
| K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corp. | KNT | Class II | |
| K051535 | Modification To:registrado X-Tra | Voco GmbH | ELW | Class II | |
| K051521 | Regius Rs-1000, Medical Image Processing Workstation | Konica Minolta Medical & Graphic, Inc. | LLZ | Class II | |
| K051512 | Cac-127-8 Cardoac Array Coil | Invivo Corporation | MOS | Class II | |
| K051059 | Amsure 100% Silicone Foley Catheter | Amsino International, Inc. | EZL | Class II | |
| K051037 | Imageqube Pacs | Intuitive Imaging Informatics, LLC | LLZ | Class II | |
| K050967 | Varelisa Recombi Ctd Screen, Model 13096 | Sweden Diagnostics (Germany) GmbH | LJM | Class II | |
| K050954 | Microplex Coil System (Mcs) and Hydrocoil Embolic System (Hes) | Terumo Cardiovascular Systems Corporation | HCG | Class II | |
| K050728 | Open Breast Coil (Obc) with Biopsy Plates | GE Healthcare Coils | MOS | Class II | |
| K050178 | Hba1c Enzymatic Assay | General Atomics | LCP | Class II | |
| K051331 | 19-Inch (48 Cm) Color Lcd Monitor Cdl1902a | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050779 | Cynergy Multiplex Laser | Cynosure, LLC | GEX | Class II | |
| K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Medical | NBW | Class II | |
| K050236 | Fishview | Applied Spectral Imaging, Ltd. | LNJ | Class II | |
| K050036 | Fes Cycle Ergometer, Model Rt300-S | Restorative Therapies Inc. | GZI | Class II | |
| K042939 | Capillary's Immunotyping (Pn 2100) | Sebia | DFH | Class II | |
| K042630 | Revlight Skin Care System | Skincare Technology, Inc. | GEX | Class II | |
| K051546 | Bpcalibrator Mc3000/mc3100 | Healthstats International Pte., Ltd. | DXN | Class II |