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 2026-10-08, 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 3359 of 3526

510(k) clearances, page 3359 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800658	Rst-Series Control	Gamma Biologicals, Inc.	KSF	Class II	1980-04-16
K800657	Ferritin Controls Code Qas.104	Amersham Corp.	DBF	Class II	1980-04-16
K800655	Model 100 Spectraview	Edwards Laboratories	DQC	Class I	1980-04-16
K800647	Norsen Debrider	MEDLINE INDUSTRIES, LP - Northfield	GEN	Class I	1980-04-16
K800644	Cyberlith Implantable Pulse Gen. #253-02	Intermedics, Inc.	DXY	Class III	1980-04-16
K800606	Micromedic Automatic Diluter	Micromedic Systems	JQW	Class I	1980-04-16
K800600	B-D Staset, i.v. Flow Controller	BD Becton Dickinson Vacutainer Systems Preanalytic	FPA	Class II	1980-04-16
K800578	Surgivac Tm	Snyder Laboratories, Inc.	GCY	Class I	1980-04-16
K800577	Snyder Hemovac Tm Vented Wound Kit	Snyder Laboratories, Inc.	GCY	Class I	1980-04-16
K800570	Heparin Pump #7420	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1980-04-16
K800543	Snyder Hysterectomy Y Tube Kit	Snyder Laboratories, Inc.	GCY	Class I	1980-04-16
K800528	Shield Perfect Fit; Dura-Fit, Dispos.	American Convertors Div., American Pharmaseal	FXP	Class I	1980-04-16
K800511	Shield Lucky Cap; Blossom Bouffant Cap	American Convertors Div., American Pharmaseal	FYF	Class I	1980-04-16
K800488	Surgery Display System	Kent Barker & Assoc.	DRQ	Class II	1980-04-16
K800482	Stearothermohilus Spore Strips	Mdt Corp., Inc.	FRC	Class II	1980-04-16
K800403	Mcgaw/epic i.v. Admin. Set	American Hospital Supply	FPA	Class II	1980-04-16
K800375	Nomos-01 Pulse Generator	Biotronik Sales, Inc.	DXY	Class III	1980-04-16
K800358	Y-Type Infusion Set (2 Lead)	Haemonetics Corporation	FPA	Class II	1980-04-16
K800357	Bi-Level Assayed Card. Drug Cont., i,ii	Ortho Diagnostics, Inc.	LAS	Class I	1980-04-16
K800346	Hemosafe	Med Lab Systems, Inc.	GKL	Class II	1980-04-16
K800298	Usci Bipolar Ballon Pacing Electrode	C.R. Bard Inc	LDF	Class II	1980-04-16
K800191	Peritone	Laurie Ann Kaiser, Ph.D.	HIR	Class II	1980-04-16
K800758	Tenzcare Dual-Channel Stimulator	3M Company	GZJ	Class II	1980-04-10
K800748	Snap-Way Headgear	Northwest Orthodontics, Inc.	DZB	Class II	1980-04-10
K800735	U-Style Adapter	American Midwest	EGS	Class I	1980-04-10
K800713	Mj Percussor	Cussionair Therapy Products, Inc.	BYI	Class II	1980-04-10
K800701	T-570 Tinnitus Masker	Audiotrone	KLW	Class II	1980-04-10
K800646	Ames Tda Theophyl-Line Test	Miles Laboratories, Inc.	KLS	Class II	1980-04-10
K800641	Centrifi Chem Ast/sgot	Union Carbide Corp.	CIT	Class II	1980-04-10
K800635	C.c.-Pak	Respiratory Care, Inc.	JOL	Class II	1980-04-10
K800628	Kodak Ektachem Clinical Chem. Slides	Eastman Kodak Company	JGS	Class II	1980-04-10
K800616	Bun Reagent Kit #88108	Hi Chem, Inc.	CDS	Class II	1980-04-10
K800609	Catheter Stylet	G.D. Searle and Co.	KOD	Class II	1980-04-10
K800604	Ck Isoenzyme Electrophoresis Control-I.d	Beckman Instruments, Inc.	JJT	Class I	1980-04-10
K800601	Hydragamma 16	Innotron of Oregon, Inc.	JJJ	Class I	1980-04-10
K800554	Multi-Format Sfd Model 1720	Philips North America LLC	IXL	Class II	1980-04-10
K800549	Model Triex-L Hollow Fiber Dialyzer	Extracorporeal Medical Specialities, Inc.	FJI	Class II	1980-04-10
K800532	S.k. Diag. Ultrasound Body Scanner	Smithkline Diagnostics, Inc.	IYO	Class II	1980-04-10
K800531	S.k. Diag. Ultrasnd. Small Parts Scan	Smithkline Diagnostics, Inc.	IYO	Class II	1980-04-10
K800501	Pfizer/as&e 0450 Localizer	Pfizer Medical Systems, Inc.	JDX	Class II	1980-04-10
K800434	Portable Medical Ultrasound Scanner	Bion Ent., Ltd.	IYO	Class II	1980-04-10
K800424	Lundia Plate Disp.	Gambro, Inc.	FJG	Class II	1980-04-10
K800393	Poly Sulfide Impression Paste W/catalyst	American Dental Research	ELW	Class II	1980-04-10
K800392	Bracket Bonding System Metal & Plastic	American Dental Research	DYH	Class II	1980-04-10
K800391	Paint-on-Restorative W/fissure Sealer	American Dental Research	EBC	Class II	1980-04-10
K800390	Ant. & Post. Restorative Powder Liq.	American Dental Research	KLE	Class II	1980-04-10
K800389	Anterior & Post. Restorative Paste Sys.	American Dental Research	KLE	Class II	1980-04-10
K800243	D668 & D664 Central Monitoring Systems	Medtel Pty., Ltd.	DRT	Class II	1980-04-10
K800164	413A Neonatal Monitor	Xerox Corp.	FLS	Class II	1980-04-10
K800733	Double-Edge Curette	Stainless Mfg., Inc.	HXP	Class I	1980-04-08