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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K870969 | Cortisol-Ria Kit Coated Tube Radioimmunoassay Kit | Canadian Bioclinical, Ltd. | CGR | Class II | |
| K870968 | Total T3-Ria Kit Coated Tube Radioimmunoassay Kit | Canadian Bioclinical, Ltd. | CDP | Class II | |
| K872245 | Proview (E7015) & Prolink Image Display System | General Electric Co. | IXC | Class I | |
| K872151 | Ophthalmic Cannula | Pharmacia, Inc. | HMX | Class I | |
| K872136 | 12.5Mm Peyman Wide Field Yag Laser Lens | Ocular Instruments, Inc. | HJK | Class II | |
| K872087 | Umsc Holter Monitoring Kit | United Medical Supply Co., Inc. | DSH | Class II | |
| K872063 | Tandem-E Immunoenzymetric Assay for Ckmb II | Hybritech, Inc. | JHY | Class II | |
| K871936 | Canon Surgical Auto Keratometer Sk-1 | Canon Medical Components U.S.A., Inc. | HLQ | Class I | |
| K871847 | Bt-795/Ats | Electromedics, Inc. | CAC | Class II | |
| K871827 | Omega III Angiographic Table, Rotation & Stepper | General Electric Co. | KXJ | Class II | |
| K871794 | Easy Read(tm) | Health O Meter | DXN | Class II | |
| K871663 | Pmt Traction Tongs | Progress Mankind Technology | HAX | Class II | |
| K871605 | Mvs 2.5Mm, 4.0Mm, 6.0Mm Infusion Cannula | Advanced Surgical Products, Inc. | HMX | Class I | |
| K871454 | Morgan Therapeutic Lens | Mortan, Inc. | KYG | Class I | |
| K871436 | Predictor | Corazonix Corp. | DQK | Class II | |
| K871367 | Hy-Flow Non-Rebreathing Valve Assembly | Med Air Technology, Inc. | CBP | Class II | |
| K870066 | Kay-Plus & Various Vania Sanitary Liners & Pads | Cascades Psh, Inc. | HHL | Class II | |
| K864994 | 40Cc per. Pre-Furl (S/l) Intra-Aortic Catheter | Aries Medical, Inc. | DSP | Class II | |
| K864537 | 40Cc Percutaneous Pre-Furl (D/l) Balloon Catheter | Aries Medical, Inc. | DSP | Class II | |
| K872127 | D-Scope II and D-Scope Iic | Medx, Inc. | IYX | Class I | |
| K872078 | Qc3 Whole Human Serum, Hdl-Cholesterol Control | Solomon Park Research Laboratories, Inc. | DER | Class II | |
| K871809 | Flexible Biopsy Forcep | Surgi-Aid Endoscopics, Inc. | OCZ | Class II | |
| K871686 | Gem-Crit Check | Diamond Sensor Systems | DRY | Class II | |
| K871571 | Neurotips(tm) | Ulster Scientific, Inc. | GXB | Class I | |
| K870534 | Dotolo Colon Hydrotherapy Instrument | Dotolo Research Corp. C/O Keller and Heckman | KPL | Class II | |
| K870400 | Scx Information Management System | General Electric Co. | KPR | Class II | |
| K864610 | Cilas Ym 101 Nd:yag Laser for Neurological Use | Inframed, Inc. | LLF | Class III | |
| K872177 | Tipsep-Cortisol Ria Diagnostic Kit | Nuclear Diagnostics, Inc. | CGR | Class II | |
| K872122 | 8000 Series Gas Chromatographs | Revvity Health Sciences, Inc. | KZQ | Class I | |
| K872108 | Abbott Spectrum Bicarbonate Reagent Kit | Abbott Medical | KHS | Class II | |
| K872104 | Kodak Ektachem 700P Analyzer | Eastman Kodak Company | JJE | Class I | |
| K872103 | Kodak Ektachem 700S Analyzer | Eastman Kodak Company | JJE | Class I | |
| K872029 | Uni-Fast Creatine Kinase Test (Ck) | Sclavo, Inc. | JHS | Class II | |
| K872015 | Spiraseal(tm) Face Mask (Various Sizes) | Brigam, Inc. | BSJ | Class I | |
| K871981 | Bilateral Continuous Passive Motion Device | Avec Scientific Design Corp. | BXB | Class I | |
| K871942 | Perm-Cath Catheter Kit | Quinton, Inc. | LFJ | Class II | |
| K871892 | Technicon Ra(r) Systems & Assist(r) Clin. Analyzer | Technicon Instruments Corp. | KNK | Class I | |
| K871888 | Digital Fever Thermometer Model Mc-5 | Omron Electronics, Inc. | FLL | Class II | |
| K871831 | Patho Dx Latex Agglutination Strep Grouping Kit | Siemens Healthcare Diagnostics Inc. | GTZ | Class I | |
| K871788 | Liquid Tdm Controls | Biological Industries | DIF | Class I | |
| K871779 | Helical Stone Basket (Disposable) | Van-Tec, Inc. | FFL | Class II | |
| K871777 | Van-Tec Reusable Helical Stone Basket | Van-Tec, Inc. | FFL | Class II | |
| K871749 | Adult Perm-Cath 40Cm. | Quinton, Inc. | LFJ | Class II | |
| K871708 | Neo-I Temperature & Conductivity Meter | Automata, Inc. | FIZ | Class II | |
| K871620 | Allelix Group a Streptococcus Detection Kit | Allelix, Inc. | GTZ | Class I | |
| K871589 | Theophylline Fpia Controls | Sigma Chemical Co. | LAW | Class I | |
| K871546 | Safeside(tm) Lumed | Luther Medical Products, Inc. | FOZ | Class II | |
| K871497 | Liner or Gsri-Pnf | Gulf South Research Institute | EBI | Class II | |
| K871449 | Oncology Spt Sys #Ms-C10 Medication Reservoir Bag | Pa Medical Corp. | KPE | Class II | |
| K871303 | Delfia(tm) Thyroxine (T4) Kit | Lkb Instruments, Inc. | CDX | Class II |