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 3232 of 3528

510(k) clearances, page 3232 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K820650	Lps 1118	L.P. Systems Corp.	KCW	Class I	1982-04-29
K820519	Biopser	Advanced Biomedical Instruments	HFB	Class I	1982-04-29
K820438	Quinton Q2000 Ett Monitoring System	Quinton, Inc.	DSI	Class II	1982-04-29
K820326	Bigston Transcutaneous Nerve Stimulat	Canadian Medical Products	GZJ	Class II	1982-04-29
K820166	Adaptation of Kantron 40 Cc. Pdliab	Kontron Instruments, Inc.	DSP	Class II	1982-04-29
K820024	Digital Clinical Thermometer	Faith & Firsts Enterprises Co., Ltd.	FLL	Class II	1982-04-29
K827345	Vhr Video System	General Electric Co.			1982-04-28
K820537	Ultrasonic Toothbrush	Ultrasonic Plaque Control Laboratories	JEQ	Class I	1982-04-27
K820396	Automated Blood Cell Separ. Disp. Sftwr	Pheragen Technology Corp.	GKT	Class II	1982-04-27
K821045	Non Conductive Pediatric Anes. Face	Vital Signs, Inc.	BSJ	Class I	1982-04-26
K821036	Enternal Solution Admin. Set	Corpak Co.	KNT	Class II	1982-04-26
K821028	Finger Cots	Abco Dealers, Inc.	FMC	Class I	1982-04-26
K821019	Phosphate Buffered Clycerol Mounting Flu	Microbiological Research Corp.	LEB	Class I	1982-04-26
K821016	Quadruple Jogger Exerciser	Industrial Energy Specialists, Inc.	BXB	Class I	1982-04-26
K821000	Enzymune-Test Digoxin	Icl Scientific	DON	Class II	1982-04-26
K820991	Kenz-Gelect Gel Pad	Suzuken Co., Ltd.	GYB	Class II	1982-04-26
K820983	Hot Biopsy Forceps W/round Cups	Mill-Rose Laboratory	GEI	Class II	1982-04-26
K820980	Biopsy Forceps W/oval Cup & Needle	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820976	Gil Chem Magnesium Reagent	Gilford Diagnostics	JGJ	Class I	1982-04-26
K820975	Gilchem Acid Phosphatase Reagent	Gilford Diagnostics	CKB	Class II	1982-04-26
K820972	Biopsy Forceps W/oval Cups	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820970	Retrieval Forceps W/rattoothed Jaws	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820969	Biopsy Forcepw W/small Oval Cups	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820968	Retrieval Forceps W/alligator Jaws	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820967	Biopsy Forceps W/alligator Type Cups	Mill-Rose Laboratory	GEN	Class I	1982-04-26
K820951	Enzymatic Cholesterol Kit	Anco Medical Reagents & Assoc.	CHH	Class I	1982-04-26
K820950	Total Cholesterol Reagent Set	Sterling Biochemical, Inc.	CHH	Class I	1982-04-26
K820947	Nova III Fluids Pack	Shaban Mfg. Co.	JIX	Class II	1982-04-26
K820937	Ackrad Fluid Connecting Set	Ackrad Laboratories	LHI	Class II	1982-04-26
K820902	Multiperfectemp	Kay Medical, Inc.	GEI	Class II	1982-04-26
K820900	Emit Urine Methadone Assay #3E319	Syva Co.	DDE	Class I	1982-04-26
K820870	Ureteral Stant Set	Van-Tec, Inc.	FAD	Class II	1982-04-26
K820868	Ureteral Catheter Connector	Van-Tec, Inc.	KOD	Class II	1982-04-26
K820866	Ureteral Catheter Connecting Tube	Van-Tec, Inc.	KOD	Class II	1982-04-26
K820835	Alumina Silica-Activated Partial Throm	Hyland Therapeutic Div., Travenol Laboratories	GFO	Class II	1982-04-26
K820779	Ote Biomedical #1296 - 16 Chan. Record	Del Mar Avionics	GWQ	Class II	1982-04-26
K820720	Respirator Monitor	Rv Systems	CAP	Class II	1982-04-26
K827177	Ltrasonic Scanner u.s. Aloka Ssd-500	Aloka Co., Ltd.			1982-04-25
K827291	Model Pup II and Mini-Nebulizer	Biermar AG			1982-04-23
K820784	Clinic 2000 Model Multi-Frecodyn Device	Dimeco	IPF	Class II	1982-04-22
K827289	Digital Radiography System	Diagnostic Technology, Inc.			1982-04-21
K827288	Mlx Lateral Imaging System	General Electric Co.			1982-04-21
K827285	Model Ssd-710	Aloka Co., Ltd.			1982-04-21
K827284	Model Ssd-119	Aloka Co., Ltd.			1982-04-21
K821402	Light Weight Aluminum Canes	Manuco Manufacturing Co., Inc.	IPS	Class I	1982-04-21
K821010	Bathtub Transfer Bench	Guardian Products Co., Inc.	IKX	Class I	1982-04-21
K821009	Bathtub Grab Bar	Guardian Products Co., Inc.	ILS	Class I	1982-04-21
K820963	Patient Pal i.v. Walker	Pryor Products	FOX	Class I	1982-04-21
K820931	Hank's 199 Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21
K820930	Fischer's Powdered Medium	Dutchland Laboratories, Inc.	KIT	Class I	1982-04-21