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 |
|---|---|---|---|---|---|
| K890987 | Vinyl Patient Examination Glove | Jm Gloves Co., Ltd. | LYZ | Class I | |
| K890356 | Latex Examination Gloves Non-Sterile | Quest Intl., Inc. | LYY | Class I | |
| K890187 | The C-S Distraction Rod Assembly | Mizuho Orthopedic Systems Inc | KWP | Class II | |
| K890185 | C-S Impactor | Mizuho Orthopedic Systems Inc | LYP | Class II | |
| K890141 | Devilbiss Model 1400D (Oxygen Conserving Device) | Devilbiss Health Care, Inc. | NFB | Class II | |
| K890080 | Phacoemulsifier Model 100 | Sonic Needle Corp. | HQC | Class II | |
| K883880 | Katzen Thrombolysis Guidewire | Medi-Tech, Inc. | DQX | Class II | |
| K883784 | Tsrh Anterior Spinal Screws, Staples and End Plate | Warsaw Orthopedic, Inc. | LYQ | Class I | |
| K883783 | Tsrh Sacral Spinal Screw | Warsaw Orthopedic, Inc. | KWP | Class II | |
| K891300 | Non-Sterile Patient Examination Glove | Shun Thai Rubber Gloves Industry Co., Ltd. | LYY | Class I | |
| K891236 | Fdx Solid State Video Camera Model 5950 | Medical Dynamics, Inc. | FWD | Class I | |
| K890717 | Modification Hemofiltration Catheter HF-100 | Vas-Cath, Inc. | LFK | Class II | |
| K890593 | Patient Examination Glove | Industri Getah Jacon | LYY | Class I | |
| K890426 | Consummate Air Therapy Bed | Health Products, Inc. | FNL | Class II | |
| K890322 | Slt Contact Laser System (ENT, Head & Neck Surg.) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K890321 | Slt Contact Laser System (Orthopedics) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K890286 | Sharplan Model 750 Remote Control Unit (Rcu) | Sharplan Lasers, Inc. | GEX | Class II | |
| K890202 | Tele-Temp Thermometer | Rocky Mountain Medical Corp. | FLL | Class II | |
| K890116 | Enteral Feeding Tube | Hdc Corp. | FPD | Class II | |
| K882206 | Supermon Arrhythmia Module 7270 | Kontron Instruments, Inc. | DSI | Class II | |
| K891649 | Patient Examination Gloves (Latex) | Lic-Orthion | LYY | Class I | |
| K891469 | Alt (Gpt) Ifcc 2-Vial Reagent W/pyridoxyl Phosphat | Trace Scientific, Ltd. | CKA | Class I | |
| K891416 | Patient Examination Gloves (Latex) | Sampson Development Corp. | LYY | Class I | |
| K891330 | Non-Sterile Patient Examination Gloves | Galaxy Intl., Inc. | LYY | Class I | |
| K891329 | Sterile Patient Examination Gloves | Galaxy Intl., Inc. | LYY | Class I | |
| K891025 | Total Bilirubin for Continuous Flow | Catachem, Inc. | CIG | Class II | |
| K890986 | Vinyl Patient Examination Glove | Precious Mountain Ent. Corp. | LYZ | Class I | |
| K890984 | Linistain Sls | Shandon, Inc. | KIO | Class I | |
| K890982 | Butterfly Globe (Patient Examination Glove) | O.L. Trading, Inc. | LYY | Class I | |
| K890873 | Glucofilm Test Strips & Controls/glucometer 3 | Kulzer GmbH | CGA | Class II | |
| K890863 | Trojan for Women | Armkel, LLC | HIS | Class II | |
| K890774 | Giardeia(tm) | Antibodies, Inc. | KHW | Class II | |
| K890431 | Pleur-Evac(r) a-8000--Adult/pediatric Chest Drain | Deknatel, Inc. | GCX | Class II | |
| K884511 | Safe Multiport Injector | L & W Ent. | FPA | Class II | |
| K884176 | Chromatography Kit | Gelman Sciences, Inc. | DPA | Class I | |
| K891395 | Radkor Bs-10 and Bs-10T | Radkor, Inc. | IXY | Class I | |
| K890815 | Magnetic Resonance Diagnostic Device Accessories | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K890473 | Needle Guard(tm) | Martech Medical Products | FMI | Class II | |
| K890077 | Traumafuse Rapid Infusion Device | The Traumafuse Co. | DTN | Class II | |
| K884560 | Scimed Ecmotherm(tm) Heat Exchanger | Scimed Life Systems, Inc. | DTR | Class II | |
| K884323 | Ximaview(tm) | Varian Assoc., Inc. | KPQ | Class II | |
| K880259 | Visual Reinforce. Audio Cassette Unit: Basic & Adv | Colorado Hearing Systems, Inc. | LYN | Class II | |
| K873038 | Techton Protective Pad | Techton, Inc. | IWQ | Class I | |
| K891697 | Abuscreen Fp Benzodiazephine Reagent | Roche Diagnostic Systems, Inc. | JXM | Class II | |
| K891571 | Percussion Hammer | Sandal Surgico | GWZ | Class I | |
| K891546 | Patient Examination Gloves (Latex) | Ap Intl., Inc. | LYY | Class I | |
| K891501 | Patient Examination Gloves (Latex) | Tan Chong Rubber Gloves Sdn Bhd | LYY | Class I | |
| K891372 | Orthodontic Plastic Bracket | American Orthodontics | DYW | Class II | |
| K891368 | Patient Examination Gloves (Latex) | Zest Mark Industrial Co., Ltd. | LYY | Class I | |
| K891328 | Preformed Template for Tooth Positioner | American Orthodontics | KMY | Class I |