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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
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	2,569

176,366 records, page 3333 of 3528

510(k) clearances, page 3333 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802331	Ao Flexible Laryngoscope, #Ls-7	American Optical Corp.	CAL	Class I	1980-10-10
K802328	Disp. Tougy-Borst Type Adaptor W/port	Stanco Medical, Inc.	DTZ	Class II	1980-10-10
K802327	Sheath Dilator Set	Stanco Medical, Inc.	DRE	Class II	1980-10-10
K802326	Pressure Monitoring Lines	Stanco Medical, Inc.	DRI	Class I	1980-10-10
K802324	E1 Series Hearing Aid	Western Advanced Technology, Inc.	ESD	Class I	1980-10-10
K802319	Hemotemp Tm	Marion Laboratories, Inc.	KSE	Class II	1980-10-10
K802307	Widex Hearing Aid #'S A12+t & A12+h	Hearing Aid Co.	ESD	Class I	1980-10-10
K802306	Widex Hearing Aid #'S A18+t & A18+h	Hearing Aid Co.	ESD	Class I	1980-10-10
K802305	Mlc-4200 Cardiac Output Computer	Nihon Kohden America Inc	DXG	Class II	1980-10-10
K802282	Esophageal ECG Preamplifier & Signal Con	Consolidated Medical Equipment Company	DRR	Class II	1980-10-10
K802280	White Knight Drape Seal	G.D. Searle and Co.	KKX	Class II	1980-10-10
K802277	Kotex Lightdays Deodorant Pantiliners	Kimberly-Clark Corporation	HHL	Class II	1980-10-10
K802260	Vascular Catheter Wireguides	Stanco Medical, Inc.	DQX	Class II	1980-10-10
K802245	7 Tricyclic Antide Pressants	Technicon Instruments Corp.	LFI	Class II	1980-10-10
K802234	Bedside Tinnitus Masker #1500	Marpac, Inc.	KLW	Class II	1980-10-10
K802233	Glycosylated Hemoglobin-Smc Column	Helena Laboratories, Corp.	LCP	Class II	1980-10-10
K802231	Air Viva II	General Medical Co.	BTM	Class II	1980-10-10
K802222	Anterior Kyphosis Distraction Device	Zimmer GmbH	KWQ	Class II	1980-10-10
K802213	White Knight Bovie Cord/suction Tube	G.D. Searle and Co.	KKX	Class II	1980-10-10
K802185	Arterial Blood Sampling Kit	Current Technologies, Inc.	FMP	Class I	1980-10-10
K802178	Minocycline 30 Mcg. Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1980-10-10
K802164	8-Hydroxyquinoline, Cresolphthalein Com.	Panmed, Inc.	CIC	Class II	1980-10-10
K802163	Chloride Color & Chloride Sample Diluent	Panmed, Inc.	CHJ	Class II	1980-10-10
K802162	CO2 Color Reagent & CO2 Sample Diluent	Panmed, Inc.	KMS	Class II	1980-10-10
K802161	Biuret Reagent & Total Protein Blank Sol	Panmed, Inc.	CEK	Class II	1980-10-10
K802160	Bun Color Reagent & Bun Acid Used	Panmed, Inc.	CDW	Class II	1980-10-10
K802159	Ammonium Molybdate Inorganic Phosphorus	Panmed, Inc.	CEO	Class I	1980-10-10
K802158	Postassium Buffer Sol. & Wash Solution	Panmed, Inc.	CEM	Class II	1980-10-10
K802157	Bcg Reagent Serum Albumin W/technicon	Panmed, Inc.	CIX	Class II	1980-10-10
K802156	Reagents Serum Creatine Using Techicon	Panmed, Inc.	CGX	Class II	1980-10-10
K802155	Reagents Serum Sodium Using the Tech.	Panmed, Inc.	JGS	Class II	1980-10-10
K802154	Reagents Used-Quan. Measure of Serum	Panmed, Inc.	CIG	Class II	1980-10-10
K802146	Aquasonic 100 Ultrasound Trans. Gel,	Parker Laboratories, Inc.	IYO	Class II	1980-10-10
K802143	Ch-60 Plus /Abnormal Low/blood Platelet	American Dade	JPK	Class II	1980-10-10
K802142	Ch-60 Plus Whole Blood Platelet/abnornal	American Dade	JPK	Class II	1980-10-10
K802141	Ch-60 Plus Whole Blood Platelet Control	American Dade	JPK	Class II	1980-10-10
K802136	Delta Test Triglycerides	BD Becton Dickinson Vacutainer Systems Preanalytic	CDT	Class I	1980-10-10
K802135	Testosterone Radioimmunoassy Kit	Radioimmunoassay, Inc.	CDZ	Class I	1980-10-10
K802109	Kemtrol Serum Control Abnormal	Helena Laboratories, Corp.	JJY	Class I	1980-10-10
K802108	Kemtrol Serum Control-Normal	Helena Laboratories, Corp.	JJY	Class I	1980-10-10
K802097	Self-Recording Admittance Meter 709	Amplaid USA, Inc.	ETY	Class II	1980-10-10
K802095	Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1980-10-10
K802094	Ortho Spectrum	Ortho Instruments	GKL	Class II	1980-10-10
K802091	American Monitor Magnesium #'S 1036&4021	American Monitor Corp.	JGJ	Class I	1980-10-10
K802080	Baker Diag. Ultrarate Chloride Kit	J.T. Baker Chemical Co.	JFS	Class II	1980-10-10
K802068	Ultimate Direct & Total Bilirubin Contro	Beckman Instruments, Inc.	JJX	Class I	1980-10-10
K802060	Sterile Tonsil Sponges	Medspec Corp.	GDY	Class I	1980-10-10
K802034	CO2 Microsurgical Laser System #370	Metricon, Ltd.	EWG	Class II	1980-10-10
K802027	Vialon Surgeon's Gloves	Rivefain Corp.	KGO	Class I	1980-10-10
K802017	Dressing Change Set Cat.#910-930	Pollak (Intl.).ltd	KDD	Class I	1980-10-10