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 |
|---|---|---|---|---|---|
| K910716 | Model 2144.00 Combination Endo-Surgical Device | Richard Wolf Medical Instruments Corp. | FCX | Class II | |
| K910520 | Safetysnap Safety Syringe | U.S. Medical Instruments, Inc. | FMF | Class II | |
| K910452 | Respi-Pak Rt-Pak | Cns, Inc. | BZG | Class II | |
| K910384 | Video Annotator Model Pk2310 | Perkins Mfg. Co. | JAA | Class II | |
| K910321 | Y Adaptor | Akcess Medical Products, Inc. | KOC | Class II | |
| K910261 | Immulite(tm) Total T4 | Cirrus Diagnostics, Inc. | KLI | Class II | |
| K910213 | Nutrimix(r) Macro(tm) Tpn Compounder/modification | Abbott Medical | LHI | Class II | |
| K905807 | Helena Thromboplastin Reagent with Diluent | Helena Laboratories, Corp. | GJS | Class II | |
| K905498 | Stat 2 IV Pumpette | The Master Medical Corp. | LDR | Class II | |
| K905497 | Master Flow i.v. Pumpette | The Master Medical Corp. | LDR | Class II | |
| K905457 | Clinical Chemistry Quality Control Material | Consolidated Technologies, Inc. | DIF | Class I | |
| K905132 | Shimadzu Image Processor Dfs-500 | Shimadzu Medical Systems | LLZ | Class II | |
| K903298 | Dynasonic Plaque Remover & Polisher Dynatip | Micro Motors, Inc. | ELC | Class II | |
| K896151 | Emission Tomography Carousel | Atf Consolidated | KPS | Class II | |
| K911355 | Lifeport Vascu Access Syst/port Intro Kit 7015 | Strato Medical Corp. | LJT | Class II | |
| K911209 | Phonak 9300 Sc-Af Ite Hearing Instrument | Phonak, Inc. | ESD | Class I | |
| K910569 | Tyceramic | Jeneric/Pentron, Inc. | ELL | Class II | |
| K910430 | Hemocard-as | Isolab, Inc. | GHM | Class II | |
| K910325 | Ahl, Ite Model American | Bob Bare Hearing Aid Repair | ESD | Class I | |
| K910268 | Transducers, Eup-C318/v33/f334/cc331/b31/032t | Hitachi Medical Corp. | ITX | Class II | |
| K910167 | Microtek-Heritages Silicone Bulb Evacuation System | Microbio-Medics, Inc. | GCY | Class I | |
| K905687 | Zirconia Ceramic Modular Heads | Zimmer GmbH | LZO | Class II | |
| K904068 | Luxar Model Lx-20 CO2 Laser | Luxar Corp. | GEX | Class II | |
| K901955 | Periogard(r) Periopen | Colgate-Palmolive Company | EFS | Class I | |
| K911505 | Fixation Wire | Simpex, Inc. | HTY | Class II | |
| K911452 | Fixation Pin | Simpex, Inc. | HTY | Class II | |
| K911050 | Lh Irma Immunomag | Pantex, Div. Bio-Analysis, Inc. | CEP | Class I | |
| K910977 | Lanex Exam Gloves | Multi M Intl., Inc. | LYY | Class I | |
| K910872 | Ebv Igg Elisa Test | Gull Laboratories, Inc. | MCD | Class I | |
| K910857 | Alldress Multi Layered Wound Dressing | Scott Health Care | NAB | Class I | |
| K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | DXN | Class II | |
| K910732 | Candela Mini-Ub Endoscope | Candela Corporation | ODF | Class II | |
| K910674 | Flexmedics Malleable Cannula | Flexmedics | HRX | Class II | |
| K910640 | Systemate Lactate Dehydrogenase (Epos Appl) #65476 | Em Diagnostic Systems, Inc. | CFJ | Class II | |
| K910639 | Systemate Alkaline Phosphatase(epos Appl) #65483 | Em Diagnostic Systems, Inc. | CJE | Class II | |
| K910633 | Ysi Model 1500 Blood Glucose Analyzer | Yellow Springs Instrument Co., Inc. | CGA | Class II | |
| K910547 | Feldmuehle Ceramic Head (12/14 X 28Mm) | Turnkey Intergration USA, Inc. | LZO | Class II | |
| K910537 | Visi-Strep | Kev Connecticut Diagnostics, Inc. | LQL | Class I | |
| K910535 | Synchron C-Reactive Protein Reagent | Beckman Instruments, Inc. | DCN | Class II | |
| K910333 | Challenge (Tm) Liq Thera Drug Controls | Medical Analysis Systems, Inc. | DIF | Class I | |
| K910316 | Ohmeda - Low Flow Flowmeter | GE Healthcare | CAX | Class I | |
| K910307 | Cardiolab Amplifier Module (Cam) | Prucka Engineering, Inc. | DRR | Class II | |
| K910283 | Danam Datacell-18 | Danam Electronics | GKZ | Class II | |
| K910233 | Laser Photonics Ml-210 Holmium:yag Medi Lase Syst | Laser Photonics, Inc. | GEX | Class II | |
| K910104 | Anti-Fog Disposable IV Induction Cover | Central Plastic, Inc. | EYF | Class I | |
| K905693 | H-Tron V 100 Insulin Infusion Pump | Disetronic Medical Systems | LZG | Class II | |
| K905643 | Bed Red D-Dimer Whole Blood Agglutination Assay | Agen Biomedical, Ltd. | GHH | Class II | |
| K905583 | Ilc Forceps Pads | Inman Liebelt Corp. | HDA | Class II | |
| K905375 | Accent Dg Balloon Ureteral Dilator Set | Cook Incorporated | EZN | Class II | |
| K905372 | Miniature Electrodermal Response Trainer Edr-002 | Bio-Feedback Systems, Inc. | HCC | Class II |