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 |
|---|---|---|---|---|---|
| K891082 | Ceramic Total Hip Ball Head, Large Taper | Depuy, Inc. | LZO | Class II | |
| K890556 | Tdp Infrared Heat Lamp | Toxicology Professionals, Inc. | ILY | Class II | |
| K890057 | Sensititre Auto Id Plate Ap80 | Radiometer America, Inc | LQM | Class I | |
| K890048 | Quik-Dot Toxoplasmosis | Ampcor, Inc. | LLA | Class II | |
| K885282 | Assayed Cholinesterase Control | Actio, Inc. | JJX | Class I | |
| K884976 | Micro-Straight Posture Training Device | Mcdowell Ent., Inc. | LZW | Unclassified | |
| K883293 | Storz Dx Center:impedance Test W/rhino & Audio Opt | Storz Instrument Co. | ETY | Class II | |
| K893529 | Combolaser Model 5050 | Lasermatic, Inc. | GEX | Class II | |
| K893478 | Da-16 and Da-24 Shunt Adapters | Akcess Medical Products, Inc. | FKN | Class II | |
| K893462 | Nu-Trap Suction Catheter W/mucus Trap | Atheus Corp. | BSY | Class I | |
| K893438 | T Series Vessel Tips | Akcess Medical Products, Inc. | FKW | Class II | |
| K893231 | Delclamp | Delmed, Inc. | KDJ | Class II | |
| K893188 | Quinton Single Lumen Catheter | Quinton, Inc. | MPB | Class II | |
| K892852 | Site Phaco Plus Infusion Sleeve | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K892056 | Surgical Latex Sterile Gloves | Modern Rubber Industrial Co., Ltd. | KGO | Class I | |
| K892051 | Rubella-Cube(tm) | Difco Laboratories, Inc. | LFX | Class II | |
| K891997 | Catalog #2270Aax, 2270Dax Beltless Tocotransducer | Corometrics Medical Systems, Inc. | HFM | Class II | |
| K891755 | Dual Lumen Sub-Clavian Cath Kit, Dlsc 600K & 800K | Akcess Medical Products, Inc. | LFJ | Class II | |
| K891753 | Dual Lumen Sub-Clavian Catheter, Dlsc 600 & 800 | Akcess Medical Products, Inc. | LFJ | Class II | |
| K891584 | S 22 Instrument Stand | Carl Zeiss, Inc. | HRM | Class I | |
| K891539 | Cti II Straight Stem | Mizuho Orthopedic Systems Inc | LWJ | Class II | |
| K891297 | Playtex Portables Non-Deodorant & Doed. Tampons | Playtex Family Products, Inc. | HIL | Class II | |
| K890921 | Data Exchange System, Model 24 | Siemens Life Support Systems | CBK | Class II | |
| K890730 | Medsurg Epidural Tray 19 Gage/econ/bullet Tip 1000 | Medsurg Industries, Inc. | CAZ | Class II | |
| K890489 | Extension Set W/flow Regulator | Baxter Healthcare Corporation | FPA | Class II | |
| K884959 | Respitrak | Non-Invasive Monitoring Systems, Inc. | BZK | Class II | |
| K884521 | Star Sync | Infrasonics Corp. | CBK | Class II | |
| K883865 | External Jet Synchronizer, Model Ams-1010 | Acutronic Medical Systems AG | CBK | Class II | |
| K893415 | Trans-Oral Depth Gauge | Ruggles Corp. | LYQ | Class I | |
| K893237 | Argenco W | Argen Precious Metals, Inc. | EJT | Class II | |
| K892919 | Latex Disposable Examination Gloves | Union Industrial Co., Ltd. | LYY | Class I | |
| K892863 | Easy-Test Iron (Iron) Item No. 16686 | Em Diagnostic Systems, Inc. | JIY | Class I | |
| K892238 | Cla 200 Chempro(r) Lipid Analyzer | Johnson & Johnson Professionals, Inc. | CHH | Class I | |
| K892144 | Modified Ultima Lite | Deringer-Ney, Inc. | EJT | Class II | |
| K892099 | Patient Examination Gloves (Latex) | Tung Kuang Rubber Factory Co., Ltd. | LYY | Class I | |
| K892050 | Helena Thromboplastin Reagent | Helena Laboratories, Corp. | GJS | Class II | |
| K892003 | Abrakadabra - Dental Adhesive System | Parkell, Inc. | KLE | Class II | |
| K891474 | Tampax Ultrafit Panty Shields - Mofification | Tambrands Inc. | HHD | Class I | |
| K891473 | Tampax Ultrafit Panty Shields/dedorant-Modificatio | Tambrands Inc. | HHL | Class II | |
| K891454 | Exeter II Total Hip System | Howmedica Corp. | JDI | Class II | |
| K891452 | Spectra Ultrasound System W/color Flow Module | Diasonics, Inc. | IYO | Class II | |
| K891296 | Atraumax(tm) Surgical Clamps | Applied Vascular Devices, Inc. | DXC | Class II | |
| K890844 | Microsept 60/20 | Arbor Technologies, Inc. | CAK | Class II | |
| K890842 | 2400 Audiometer, Impedance Meter & Hrng. Aid Analy | Maico Hearing Instruments, Inc. | EWO | Class II | |
| K890043 | Dentclean Concentrated Denture Cleanser | K-P Co. | EFT | Class I | |
| K885173 | Mix Container W/attached Transfer Set | Medical Support Systems | KPE | Class II | |
| K884942 | Monaghan Rvm, Model 761 | Monaghan Medical Corp. | BZK | Class II | |
| K893244 | Argenco Wr+ | Argen Precious Metals, Inc. | EJT | Class II | |
| K893238 | Argenco Wlf | Argen Precious Metals, Inc. | EJT | Class II | |
| K893228 | Argenco W-Lite | Argen Precious Metals, Inc. | EJT | Class II |