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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K862584 | Osteotomy Drainage Tube | Treace Medical, Inc. | GBS | Class I | |
| K862456 | Nd:yag Laser 4000/6000/8000 Endometrial Ablation | Cooper Lasersonics, Inc. | HHR | Class II | |
| K862310 | Cabot Medical Variable Flow Insufflator | Cabot Medical Corp. | HES | Class II | |
| K862303 | Becker External Drainage/monitor Sys Lumbar Cath. | Pudenz-Schulte Medical Research Corp. | JXG | Class II | |
| K862000 | Keymed Flexible Esophageal Dilators | Keymed, Inc. | KNQ | Class II | |
| K861961 | Camino Csf Drainage System Model 040 | Camino Laboratories, Inc. | JXG | Class II | |
| K861913 | Slender Regular Tampax Tampons | Tambrands Inc. | HEB | Class II | |
| K861912 | Super Plus Tampax Tampons | Tambrands Inc. | HEB | Class II | |
| K861911 | Super Plus Petal Soft Plastic Appli. Tampax Tampon | Tambrands Inc. | HEB | Class II | |
| K861910 | Super Petal Soft Plastic Applicator Tampax Tampons | Tambrands Inc. | HEB | Class II | |
| K861909 | Regular Petal Soft Plastic Appli. Tampax Tampons | Tambrands Inc. | HEB | Class II | |
| K861908 | Tampax Original Regular Tampon | Tambrands Inc. | HEB | Class II | |
| K861907 | Tampax Super Tampons | Tambrands Inc. | HEB | Class II | |
| K861906 | Tampax Junior Tampons | Tambrands Inc. | HEB | Class II | |
| K861844 | Glucofacts Data Management System | Miles Laboratories, Inc. | JQP | Class I | |
| K861629 | Komai CT-Stereotactic Apparatus and Accessories | Downs Surgical, Ltd. | HAW | Class II | |
| K861098 | Seroiden Strepto Kit 'Eiken' | Syn-Kit, Inc. | GTZ | Class I | |
| K860458 | Electrophysiological System to Monitor Skin Temp. | Oxford Medilog, Inc. | OLV | Class II | |
| K860378 | Mind Map (20 Channel EEG) | Mind Systems Corp. | OLT | Class II | |
| K853117 | Cooper Laser Sonics Nd: Yag Laser, Model 8008 | Cooper Lasersonics, Inc. | GEX | Class II | |
| K862852 | Micro-Aire Replace Otology Burs/zim Hall Sur Instr | Micro-Aire Surgical Instruments, Inc. | GFF | Class I | |
| K862804 | Spunguard Hospital Coverall | Kimberly-Clark Corporation | |||
| K862777 | Model a-8000 Ultrasonic Handpiece Cord | Advanced Medical Technology, Inc. | HQC | Class II | |
| K862722 | Tubing Connector #10-810-60 100/Pkg Non-Sterile | Mercury Enterprises, Inc. | FKY | Class II | |
| K862524 | Deknatel (R) Trephine | Deknatel, Inc. | HRH | Class I | |
| K862518 | Bausch & Lomb Vertometer V-5 | Bausch & Lomb Incorporated | HLM | Class I | |
| K862517 | Bausch & Lomb Contact Lens Viewer | Bausch & Lomb Incorporated | HLF | Class I | |
| K862467 | Schneider-Shiley Seldinger Initial Puncture Instr | Shiley, Inc. | LIT | Class II | |
| K862465 | Schneider-Shiley Occluder/flushing Cath. Stopcock | Shiley, Inc. | DQO | Class II | |
| K862275 | Arthroscope | Comeg USA, Inc. | HRX | Class II | |
| K862058 | Rapid Endoscopic Lavage System | Endovations | OCX | Class II | |
| K861863 | Modified Protective Garment | Procter & Gamble Mfg. Co. | EYQ | Class I | |
| K861862 | Dieto Container for Enteral Nutrition | Gil-Med Industries C/O Kegan & Kegan, Ltd. | KNT | Class II | |
| K861845 | Model 8-B with La-2B Attachment for Ob-Gyn Use | Directed Energy, Inc. | HHR | Class II | |
| K861183 | Intramedullary Rod | The Deca Co. | |||
| K860568 | Ultrasonic Imaging System (Modified) | Interspec, Inc. | ITX | Class II | |
| K860456 | Model 9000 Recording & Electrophysiological System | Oxford Medilog, Inc. | GWQ | Class II | |
| K862797 | Airco 2000 Series Flowmeters | Airco, Inc. | CAX | Class I | |
| K862796 | Airco Pressure Regulators | Airco, Inc. | CAN | Class I | |
| K862661 | D.l. Scope(r) Otoscope | North American Medical Products, Inc. | ERA | Class I | |
| K862556 | Sandare Glycohemoglobin Procedure | Sandare Chemical Co., Inc. | LCP | Class II | |
| K862431 | Rubella Igm Eia Test Kit | Labsystems, Inc. | LFX | Class II | |
| K862330 | Modified Oscor Py Pacing Leads | Oscor Medical Corp. | DTB | Class III | |
| K862068 | Gelman Arterial Filter (43, 33 and 21 Micron) | Gelman Sciences, Inc. | DTM | Class II | |
| K862030 | Poly-Tech Angiography Catheter | Poly-Tech Medical Device Research & Development | DQO | Class II | |
| K861779 | Glucofacts Data Printer | Miles Laboratories, Inc. | JQP | Class I | |
| K861716 | Fiax Test Kit for Mycoplasma Pneumoniae-G Antibody | Whittaker Bioproducts, Inc. | GRZ | Class I | |
| K861513 | La Diffusion Technique, Kty Cm-10 Breast Pump | Crystal Medical Products, Inc. | HGX | Class II | |
| K860921 | Neos Vs-1, Pulse Generator | Biotronik Sales, Inc. | DXY | Class III | |
| K862931 | Merivaara Obstetric Chair/bed-Model 358 | Global Medical Prods, Inc. | KNC | Class II |