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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3506 of 3526

510(k) clearances, page 3506 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K761240	Auto-Enzymatic Glucose	Harleco	CFR	Class II	1976-12-29
K761239	Auto-Inorganic Phosphorus Reagent	Harleco	CEO	Class I	1976-12-29
K761238	Auto-Inorganic Phosphorus Reagent	Harleco	CEO	Class I	1976-12-29
K761037	Intersorb Laparotomy Sponge	Chesebrough-Pond'S U.S.A. Co.	EFQ	Unclassified	1976-12-29
K760921	Air Purifier	Vitaire Corp.	FRF	Class II	1976-12-29
K760898	Goldfarb Liver Clamp	Edward Weck, Inc.	GDJ	Class I	1976-12-29
K760749	System 5 - Semi-Automated Clin. Analy	Gilford Instrument Laboratories, Inc.	JJC	Class I	1976-12-29
K761291	Central Station Monitoring System	Abbott Medical	DRT	Class II	1976-12-28
K761288	P-1 Ultrasonic Arteriograph	D. Eugene Hokanson	DPW	Class II	1976-12-28
K761077	Trend Analyzer	Eldeco	DSF	Class I	1976-12-28
K761076	Demodulator/cardiotachometer	Eldeco	DRT	Class II	1976-12-28
K761075	Sports Recorder (Sr-10)	Eldeco			1976-12-28
K761074	Dynamic Recorder (Dr-10)	Eldeco	DSH	Class II	1976-12-28
K761073	Pocket Transmitter (Pt-10)	Eldeco	DXH	Class II	1976-12-28
K760675	Electrosurgical Dispersive Plate	Aspen Laboratories, Inc.	GEI	Class II	1976-12-28
K761276	Dental Stool	Dentsply Intl.			1976-12-23
K761275	Airotos Lf Handpiece	Dentsply Intl.	DZA	Class I	1976-12-23
K761264	Options for Star Dental Opus I	Syntex Corp.	DYN	Class I	1976-12-23
K761258	Dover Low Pressure Tracheal Tube	Will Ross Co.	BTO	Class II	1976-12-23
K761244	Series 700 Patient Monitors	Spacelabs, Inc.	FLL	Class II	1976-12-23
K761143	Lithium Iodide Battery Pacemaker (#201)	Pacesetter Systems	DXY	Class III	1976-12-23
K760694	Arnco i.v. Monitor	A.R. Nelson Co., Inc.	FLN	Class II	1976-12-23
K760967	Tobramycin Ria Kit	Siemens Healthcare Diagnostics Inc.	KLB	Class II	1976-12-22
K761265	Variplan Comput. Radiotherapy	Varian Assoc., Inc.	KPQ	Class II	1976-12-21
K761259	G.e. Telemetry Monitoring	General Electric Co.	GYE	Class II	1976-12-21
K761257	Auto Total Protein	Harleco	CEK	Class II	1976-12-21
K761249	Radio Transparent ECG Electrode	Concept, Inc.	DRX	Class II	1976-12-21
K761248	Electrophoresis Accessory Mo. 3526	Gilford Instrument Laboratories, Inc.	JJN	Class I	1976-12-21
K761237	Elec. Cir. Pace. Mo. Li-2,Li-3,Li-4,Li-5	Arco Medical Products Co.	DXY	Class III	1976-12-21
K761232	Quick Cult Slide Test Fecal Occult Blood	Laboratory Diagnostics Co., Inc.	KHE	Class II	1976-12-21
K761218	Auto Total Bilirubin Reagent	Harleco	CIG	Class II	1976-12-21
K761217	Auto Total Protein	Harleco	CEK	Class II	1976-12-21
K761212	Cpk1soenzymes Determination Pro. #715-Ep	Sigma Chemical Co.	JHY	Class II	1976-12-21
K761210	Limb Lead Sel. (ECG Lead Switching Ad.)	Physio Control, Inc.	DRW	Class II	1976-12-21
K761200	Enzymatic Triglycerides (End Point)	Beckman Instruments, Inc.	CDT	Class I	1976-12-21
K761197	Cholesterol Calibrator	Beckman Instruments, Inc.	JIT	Class II	1976-12-21
K761035	Surgical Blade Handles	Parke-Davis Co.	GDZ	Class I	1976-12-21
K760946	B12/folate Sing. Tube Dual Radioassay Kt	Schwarz Mann	CDD	Class II	1976-12-21
K760937	Barrier Neuro Sheet	Surgikos, Inc.	KKX	Class II	1976-12-21
K760673	Rapi/tex-Lgm Kit	Hoechst-Roussel Pharmaceuticals, Inc.	DFT	Class II	1976-12-19
K761233	Stayfree Maxi Pads	Personal Products Co.	HHL	Class II	1976-12-17
K761230	Ammocentesis Tray (Kit)	Pharmaseal Div., Baxter Healthcare Corp.	HIO	Class I	1976-12-17
K761220	Teca Model Sp5/t Electro-Ther. Stim.	Teca, Inc.	IPF	Class II	1976-12-17
K761205	Dynatech Jd7/jd7p Colposcope	Dynatech Cryomedical Co.	HEX	Class II	1976-12-17
K761184	Rely Tampon	Procter & Gamble Mfg. Co.	HIL	Class II	1976-12-17
K761088	Depuy Modified Skeletal Traction Pin	Depuy, Inc.	JEC	Class II	1976-12-17
K760968	Central Station Repeater (Model 8032A)	Hewlett-Packard Co.	KXN	Class II	1976-12-17
K761260	Arizona Oxygen Timer Device	The John Bunn Co.	BXP	Class I	1976-12-16
K761253	Cyclodialysis Spat. 15Mm Blade Titanium	Edward Weck, Inc.	HND	Class I	1976-12-16
K761252	Weck Tying Forcep, Curved Titanium	Edward Weck, Inc.	HNR	Class I	1976-12-16