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 3335 of 3528

510(k) clearances, page 3335 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K801246	Oxford Human Milk Pasteuriser	Vickers America Medical Corp.	HGX	Class II	1980-10-03
K800956	Douch Tray-Disposable Vaginal Tray W/ben	The Healthcare Group Laboratories, Inc.	HED	Class I	1980-10-03
K800954	Douche Tray-Dispos. Vaginal Tray W/povid	The Healthcare Group Laboratories, Inc.	HED	Class I	1980-10-03
K801822	Nu-Vision Disp. Ophthalmic Dressing Tray	Summit Optics, Inc.	KYG	Class I	1980-09-30
K801786	Urine Collection Containers, #3600 &3610	The Healthcare Group Laboratories, Inc.	KOD	Class II	1980-09-30
K802272	Computer ECG Terminal	Compumed, Inc.	DSI	Class II	1980-09-26
K802258	Stopcock 2-Way, 3-Way & 4-Way	Stanco Medical, Inc.	FMG	Class II	1980-09-26
K802255	Ames Tda Phenobarbital Test	Miles Laboratories, Inc.	LET	Class II	1980-09-26
K802253	Air Compressor Adaptor Kit	Hudson Oxygen Therapy Sales Co.	BTI	Class II	1980-09-26
K802248	Disarp Original	Unoplast A/S	GAO	Class II	1980-09-26
K802247	Boundary Single-Use Drapes	Procter & Gamble Mfg. Co.	KKX	Class II	1980-09-26
K802242	3M Hi-Strength Med. Tape #1534	3M Company	KGX	Class I	1980-09-26
K802235	Micro-Bond Hi-Life Procelain & Vivere	Howmedica Corp.	EIH	Class II	1980-09-26
K802227	Anastim II Transcutaneous Electrical	Biostim, Inc.	GZJ	Class II	1980-09-26
K802226	Sechrist Series 3500 Air-Oxygen Mixer	Sechrist Industries Inc	BZR	Class II	1980-09-26
K802225	Tender-Sorb Drain Sponges	Kendall Research Center	NAB	Class I	1980-09-26
K802210	Conical Tipped Centrifuge Tube 15M	Scientific Specialties, Inc.	JQC	Class I	1980-09-26
K802207	Rion Diagnostic Audiometer	Rion Acoustic Instruments, Inc.	EWO	Class II	1980-09-26
K802198	Biometric Systolic Time Interval System	Biometric Analysis Group, Inc.	DXG	Class II	1980-09-26
K802192	Boundary Single-Use Drapes	Procter & Gamble Mfg. Co.	KKX	Class II	1980-09-26
K802189	Dentloid	U.S. Shizai Corp.	ELW	Class II	1980-09-26
K802186	Disposable Nurses Cap	Anago, Inc.	FYF	Class I	1980-09-26
K802184	Hs10 Portable Operating Room Monitor	Medtel Pty., Ltd.	DRT	Class II	1980-09-26
K802174	Argyle Suction Canister W/disp. Liner	Sherwood Medical Co.	KDQ	Class II	1980-09-26
K802173	Urihesive Strips	E. R. Squibb & Sons, Inc.	KNX	Class II	1980-09-26
K802172	Urihesive System	E. R. Squibb & Sons, Inc.	KNX	Class II	1980-09-26
K802165	Sherwood Ventilatory Muscle Trainer	Sherwood Medical Co.	BYW	Class I	1980-09-26
K802148	Boundary Single-Use Drape	Procter & Gamble Mfg. Co.	KKX	Class II	1980-09-26
K802145	2C 7140 Heated Humidifer Cannister	Travenol Laboratories, S.A.	BTT	Class II	1980-09-26
K802144	2M8101 Heated Liquid Level Controller	Travenol Laboratories, S.A.	BTT	Class II	1980-09-26
K802133	Bentley Theromodilution Catheter #Btd-7F	Bentley Laboratories, Inc.	KRB	Class II	1980-09-26
K802130	Immuno. Identification of H. Capsulatum	Nolan Biological Laboratories, Inc.	GMJ	Class II	1980-09-26
K802129	Immunodiffusion Reagents/serological	Nolan Biological Laboratories, Inc.	GMI	Class II	1980-09-26
K802128	Immunodiffussion Reagents/serological	Nolan Biological Laboratories, Inc.	JWW	Class II	1980-09-26
K802126	Isolette Incubator C-100	Narco Air-Shields	FMZ	Class II	1980-09-26
K802117	Fibri Quik	General Diagnostics	GJA	Class II	1980-09-26
K802103	ECG Recall & Edit Product Version-A3601	General Electric Co.	DSI	Class II	1980-09-26
K802093	Gabbay-Frater Suture Guide	Howmedica Corp.	FZX	Class I	1980-09-26
K802090	Drager Pressure Monitor, Self-Diagnostic	Draeger, Inc.	CAP	Class II	1980-09-26
K802089	Cardiotrak	Cardiac Pacemakers, Inc.	DXH	Class II	1980-09-26
K802081	Auld Bagger Kit	Modern Medical Systems Co.	BTM	Class II	1980-09-26
K802076	Stiff Stylets	Cardiac Pacemakers, Inc.	DRB	Class II	1980-09-26
K802072	Prot-a-Trac	Robert I. Branick, M.D.	HST	Class I	1980-09-26
K802067	Clean-Air Pollution Reduction System	Precision Fluidics Division Parker Hannifin Corp.	CBN	Class II	1980-09-26
K802064	Dupont Acalactic Acid (La) Test	E.I. Dupont de Nemours & Co., Inc.	KHP	Class I	1980-09-26
K802061	Data-Zyme Urea Nitrogen Reagent Set	Data Medical Associates, Inc.	CDQ	Class II	1980-09-26
K802053	Rionet Hearing Aid Hb-69C	Rion Acoustic Instruments, Inc.	ESD	Class I	1980-09-26
K802035	Baker Diag. Ultrarate CO2 Reagent Kit	J.T. Baker Chemical Co.	JFL	Class II	1980-09-26
K802033	Oxford Intensive Care Patient Mon. Sys	Oxford Medilog, Inc.	DSI	Class II	1980-09-26
K802028	Implantable Ventricular-Inhib. C.p. Gen	Telectronics, Inc.	DXY	Class III	1980-09-26