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 3339 of 3528

510(k) clearances, page 3339 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K801926	Sigma Procedure #880 Fibrinogin/plasma	Sigma Chemical Co.	KQJ	Class II	1980-09-09
K801924	Hi-Lo Temp Gen. Purpose Temp. Probe	National Catheter Co. Div. Mallinckrodt	FLL	Class II	1980-09-09
K801910	Insulating Sheath	Cordis US Corp.	DXY	Class III	1980-09-09
K801900	Life Cervical Adjusting Machine	Life Chiropractic College, Inc.			1980-09-09
K801885	Hancock * Obturators	Hancock Laboratories, Inc.	DTI	Class I	1980-09-09
K801883	PEEP Face Mask	Vital Signs, Inc.	BYG	Class I	1980-09-09
K801859	Cam-10 Respiratory Hose Assemblies	Lifecare Services, Inc.	BZO	Class I	1980-09-09
K801846	Electrocardiograph Electrode	Phoenix Glove Co.	DRX	Class II	1980-09-09
K801840	Surgical Bandages/sunleep Dx	Martin'S Maine Exchange	NAD	Class I	1980-09-09
K801831	Evaluator #9500 Dynamic Elec/scanner	Del Mar Avionics	DSI	Class II	1980-09-09
K801811	Palpation Enhancer	Medical Horizons Co.	LDE	Class I	1980-09-09
K801806	External Silastic Boot for Cardiac Pulse	Arco Medical Products Co.	DXY	Class III	1980-09-09
K801760	Field-Lee Brain Biopsy Needle	American V. Mueller	HAO	Class I	1980-09-09
K801727	Data-Zyme Urea Nitrogen, Colorimetric	Data Medical Associates, Inc.	CDL	Class II	1980-09-09
K801726	Hdl Cholesterol Test Kit	Mallinckrodt Critical Care	LBS	Class I	1980-09-09
K801703	Sur-Fit System Sterile o.r. Sets	E. R. Squibb & Sons, Inc.	EXB	Class I	1980-09-09
K801659	Biophtal Clinical Endothelial Microscope	Coburn Optical Ind., Inc.	HJO	Class II	1980-09-09
K801621	Vascular Graft Prosth. of Exp. Micro.	Impra, Inc.	DSY	Class II	1980-09-09
K801594	Ace Fischer External Fixation Device	Ace Orthopedic Manufacturing Co.	HXK	Class I	1980-09-09
K801573	Sapcrill Thermodetect Breast Scanner Dev	California Cardiac Systems, Inc.	KYZ	Class I	1980-09-09
K801547	Test Panel for Presump. Id/bact. Org	Micro-Media Systems, Inc.	JSP	Class I	1980-09-09
K801545	Ortho Automated Cell Counter	Ortho Instruments	GKL	Class II	1980-09-09
K801539	Assure Level II Prod. #30172	Warner-Lambert Co.	JJY	Class I	1980-09-09
K801538	Assure Level I Prod. #30171	Warner-Lambert Co.	JJY	Class I	1980-09-09
K801379	Cuffed Trachea Tube for Use W/pertrach	Frederic J. Toye, M.D.	BTO	Class II	1980-09-09
K801314	Vocon Model Vc526	Teknar, Inc.	FSO	Class I	1980-09-09
K800226	Medtronic Model 2409	Medtronic, Inc.	DXY	Class III	1980-09-09
K792724	Ams Malleable or Jonas Silicone-Silver	American Medical Systems, Inc.	FAE	Class II	1980-09-09
K802112	Pa-1 Low Pressure Alarm	Medtronic, Inc.			1980-09-06
K801969	Asnis Guided Screw Systems	Howmedica Corp.	HNC	Class I	1980-08-27
K801941	Burron Microcath Intra. Cath. Placementt	Burron Medical Products, Inc.	FOZ	Class II	1980-08-27
K801936	Pad, Examining Table	Volunteer Blind Industries, Inc.	KMN	Class I	1980-08-27
K801935	Pad, Hospital Stretcher	Volunteer Blind Industries, Inc.	FPO	Class II	1980-08-27
K801933	Drualift 500	Independent Transfer Equipment Co.	FNG	Class II	1980-08-27
K801931	Martin Trach-Secure	Acucare Medical, Inc.	BTO	Class II	1980-08-27
K801923	Biomega #423-B Blood Pressure & Pulse Ck	Bio Mega Diagnostic, Inc.	DXN	Class II	1980-08-27
K801911	Howmedica Bite Block	Howmedica Corp.	EGD	Class I	1980-08-27
K801906	Dioptron III Autorefractor	Coherent Medical Division	HKO	Class I	1980-08-27
K801905	Fonix Type 5100 Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1980-08-27
K801904	Syringe Infusion Pump #2716	Harvard Apparatus, Inc.	FRN	Class II	1980-08-27
K801894	Responder II	Clinical Microsystems Intl.	BZQ	Class II	1980-08-27
K801874	Model 86-21-1 260 Approx. 60 Drops/ventd	Y	FPA	Class II	1980-08-27
K801873	Model 86-21-0 260 Secondary Medication	Y	FPA	Class II	1980-08-27
K801872	Model 86-01-1 260 Solution Admin. Set	Y	FPA	Class II	1980-08-27
K801871	Primary Solution Admin. Set-#86-01-0 260	Y	FPA	Class II	1980-08-27
K801868	Cal-Count	Bayshore Systems Corp.	ISD	Class II	1980-08-27
K801861	Ivac 260 Series Volume Tric Infusion Con	Y	LDR	Class II	1980-08-27
K801833	Gas-Chromatographic Packing	Supelco, Inc.	DJA	Class I	1980-08-27
K801832	Model 9200 Vis-U-Scan	Del Mar Avionics	DSH	Class II	1980-08-27
K801830	Model 9300 Electrocardiovalidator	Del Mar Avionics	DSF	Class I	1980-08-27