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 2026-10-15, 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 3214 of 3528

510(k) clearances, page 3214 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821412	C-Reactive Protein Control	Syva Co.	DCK	Class II	1982-07-22
K821212	Urea Nitrogen Reagent Set	Omega Medical Electronics	CDW	Class II	1982-07-22
K821206	Sgpt-UV Reagent Set	Omega Medical Electronics	CKA	Class I	1982-07-22
K821204	Glucose(enzymatic) Reagent Set	Omega Medical Electronics	CGA	Class II	1982-07-22
K821151	Ria-Quant Fpa Test Kit	Mallinckrodt Critical Care	DAN	Class II	1982-07-22
K821001	Mcparland Scalp Vein Catheter	Renal Systems, Inc.	LFJ	Class II	1982-07-22
K820953	Ef2000	Squire, Sanders & Dempsey	IPF	Class II	1982-07-22
K820543	Barrier Antimicrobial Incise Drape	Surgikos, Inc.	KKX	Class II	1982-07-22
K820042	Ocular-Biometer 4000	Radionics, Inc.	IYO	Class II	1982-07-22
K812906	Elvi Biclot 816	Volu Sol Medical Industries	KQG	Class II	1982-07-22
K821970	Dynacor Urethral Catheter Tray	MEDLINE INDUSTRIES, LP - Northfield	KOD	Class II	1982-07-21
K821621	Pregnopost	M.M. Wolfred, Ph.D.	KDT	Class I	1982-07-21
K821579	Skin Scrub-Tray	Associated Medical Products Co.	LDR	Class II	1982-07-21
K821571	Tp440 Orthoprobe	Grove Video Corp.	GZJ	Class II	1982-07-21
K827652	Technicare Ultrasound Auto Sector B-Scan Arm Option	Technicare Corp.			1982-07-20
K827610	Ultrasound Auto Sector Cardiac Module	Technicare Corp.			1982-07-20
K822061	Lavaging Catheters	American Endoscopy, Inc.	OCX	Class II	1982-07-20
K821976	Angiography Kit	Mallinckrodt Critical Care	DQO	Class II	1982-07-20
K821973	Q-Pak Urine Toxicology Control, Unassay.	Travenol Laboratories, S.A.	DIF	Class I	1982-07-20
K821972	Hearing Aid Various Models	Panasonic Co. Div. Matsu Elec. Corp. America	ESD	Class I	1982-07-20
K821971	Valuline* Amalgam Alloy	Johnson & Johnson Professionals, Inc.	EJJ	Class II	1982-07-20
K821965	Oral Thc-Cannabinoids Direct Ria Kit	Immunalysis Corporation	LAT	Class II	1982-07-20
K821959	Cardio-Respiratory Monitor Model Cr-1	Electromed Intl., Ltd.	DRT	Class II	1982-07-20
K821950	Q-Pak Urine Toxicology Control Unassayed	Travenol Laboratories, S.A.	DIF	Class I	1982-07-20
K821946	Alt Enzyme Assay Kit	Travenol Laboratories, S.A.	CKA	Class I	1982-07-20
K821934	Bio-Cal Operation Check Kit	Bio-Analytics Laboratories, Inc.	JIS	Class II	1982-07-20
K821905	Biuret (Colorimetric) Total Protein	American Monitor Corp.	CEK	Class II	1982-07-20
K821903	Disc-O-Aid	M. Dahm International ApS	IKX	Class I	1982-07-20
K821894	Disposable Transducer Domes & Kits	American Pharmaseal Div. Ahsc	DRS	Class II	1982-07-20
K821838	Vari-Support Low Back Posture Pillow	Body Therapeutics, Inc.	CCX	Class I	1982-07-20
K821837	Vari-Support Neck Posture Pillow	Body Therapeutics, Inc.	IQK	Class I	1982-07-20
K821833	Hi-Lo Temp Skin Temperature Sensor	Mallinckrodt Critical Care	FLL	Class II	1982-07-20
K821827	Gentle-Lift Chair	Pride Health Care Equipment	INO	Class II	1982-07-20
K821808	Milburn's Backeaser	The T. Milburn Co., Ltd.			1982-07-20
K821782	Beach Anesthetic Syringe Cartr. Type	Pacific Dental Corp.	EJI	Class II	1982-07-20
K821695	Micro-Aire Replac. Drill Burs for Zimmer	Micro-Aire Surgical Instruments, Inc.	HTT	Class I	1982-07-20
K821619	The Sports Hand	Therapeutic Recreation Systems, Inc.	IRA	Class I	1982-07-20
K821208	Sgot-UV Reagent Set	Omega Medical Electronics	CIT	Class II	1982-07-20
K821205	Triglyceride Reagent Set	Omega Medical Electronics	CDT	Class I	1982-07-20
K821201	Ldh-UV Reagent Set	Omega Medical Electronics	CFJ	Class II	1982-07-20
K821821	Percutaneous Tracheostomy Device	Frederic J. Toye, M.D.			1982-07-19
K821969	Acetaminophen Stat-Pak Reagent Set	Clin Tech Diagnostics Corp.	LDP	Class II	1982-07-16
K821966	Modulus Verni-Trol Anesthetic Vaporizer	Ohio Medical Products	CAD	Class II	1982-07-16
K821945	Carbamazepine Flourescent Immunoassay	American Diagnostic Corp.	KLT	Class II	1982-07-16
K821938	Syva Advance Standardization Kit #3	Syva Co.	JIS	Class II	1982-07-16
K821937	Syva Advance Standardization Kit #2	Syva Co.	JIS	Class II	1982-07-16
K821898	Ortho Classical Pathway Compl. Test	Ortho Diagnostic Systems, Inc.	DBA	Class II	1982-07-16
K821895	Ah-1 Light-Cure Dental Composite Restor	American Midwest	EBF	Class II	1982-07-16
K821676	Preg-Phile B	Bio Diagnostic Systems, Inc.	JHJ	Class II	1982-07-16
K827584	Japanese Made Microwave Therapy Equipment	Heiwa Electronic Industrial Co., Ltd.			1982-07-14