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 3304 of 3528

510(k) clearances, page 3304 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K810530	Peri-Patch Glue Mold	Quinton, Inc.	KGZ	Class I	1981-03-24
K810518	Cast Hipped Vitallium	Howmedica Corp.			1981-03-24
K810517	Insta-Bond	Lee Pharmaceuticals	DYH	Class II	1981-03-24
K810784	Fungizone	Dutchland Laboratories, Inc.	KIT	Class I	1981-03-23
K810648	Sechrist Airway Pressure Monitor #400	Sechrist Industries Inc	CAP	Class II	1981-03-20
K810646	Or/cs Wrap	American Threshold Industries, Inc.	FRG	Class II	1981-03-20
K810620	Disposable Elbow Adaptor	Intec Medical, Inc.	BZA	Class I	1981-03-20
K810616	Miller Multi-Radius Total Knee	Zimmer GmbH	HRY	Class II	1981-03-20
K810610	Earette Hearing Aid Oticon #E27	Oticon, Inc.	ESD	Class I	1981-03-20
K810609	Pediatric Position Holder	Kaye Products, Inc.	FRP	Class I	1981-03-20
K810591	Pact Supplement	BD Becton Dickinson Vacutainer Systems Preanalytic	JSK	Class I	1981-03-20
K810580	Scotch Brand Adhesive Tape	3M Company	KGX	Class I	1981-03-20
K810572	Blade, Handle, Scalpel Forceps, Surgery	Technical Resources, Inc.	GES	Class I	1981-03-20
K810553	Pediatric Blood Culture Bottles	Gibco Laboratories Life Technologies, Inc.	JSG	Class I	1981-03-20
K810552	Cordis Pacemaker Programmers 255A & 256A	Cordis US Corp.	KRG	Class III	1981-03-20
K810510	Ya-Crypto Antibody Tube Agglutination	IMMY, Inc.	GMD	Class II	1981-03-20
K810507	Phadezym Ige Prist Test	Pharmacia, Inc.	DGC	Class II	1981-03-20
K810493	Type N Endocardial Lead	Biotronik Sales, Inc.	DTB	Class III	1981-03-20
K810492	Type Yr Endocardial Lead	Biotronik Sales, Inc.	DTB	Class III	1981-03-20
K810491	Type Yc Endocardial Lead	Biotronik Sales, Inc.	DTB	Class III	1981-03-20
K810409	Model C2100-Series Ophthalmic Cryoprobe	Medtronic, Inc.	GEH	Class II	1981-03-20
K810382	Hydroxylapatite Alveolar Ridge Main	Carbomedics, Inc.	LYC	Class II	1981-03-20
K810372	Vance Deflectable Biopsy Brush Set	Vance Products, Inc.	KOD	Class II	1981-03-20
K810371	Vance Urethal Dilator Set	Vance Products, Inc.	KOE	Class II	1981-03-20
K810370	Pollack Chain Cysourethrogram Set	Vance Products, Inc.	FGI	Class II	1981-03-20
K810368	Vance Percutaneous Malecot Nephrostomy	Vance Products, Inc.	KOB	Class II	1981-03-20
K810367	Kish Urethral Illuminated Catheter Set	Vance Products, Inc.	KOD	Class II	1981-03-20
K810358	Phototherapy Light Chamber	Paul B. Elder Co.	KGL	Class II	1981-03-20
K810336	Polypectomy Snare	Medi-Tech, Inc.	KNS	Class II	1981-03-20
K810335	Respirizer	Respirizer Co., Div. Campillary Systems, Inc.	KFZ	Class I	1981-03-20
K810331	Duo-Tel	General Electric Co.	DRG	Class II	1981-03-20
K810324	Automatic Hemoclip Applier, 527700	Edward Weck, Inc.	GDW	Class II	1981-03-20
K810315	Alternate Steriliz. for Cellulose Acet	Cordis US Corp.	FKQ	Class II	1981-03-20
K810295	Computer Interface Module	Y	FRN	Class II	1981-03-20
K810248	Msi Bone Marrow Biopsy Needle W/j Tip	Creative Research and Mfg., Inc.	GAA	Class I	1981-03-20
K810206	Dual Type Electrode	Professional Instruments Co.	GXY	Class II	1981-03-20
K810193	Trippi-Wells Dual Purpose Universal Tong	Ace Orthopedic Manufacturing Co.	HAX	Class II	1981-03-20
K810188	Auto Suture Gas Powered Disp. Lds Stapl	United States Surgical, A Division of Tyco Healthc	KBC	Class I	1981-03-20
K810187	Auto Suture Pss Skin Stapling Instrument	United States Surgical, A Division of Tyco Healthc	KBC	Class I	1981-03-20
K810175	Neo Natal Respiration Function Block	Honeywell, Inc.	BZQ	Class II	1981-03-20
K803247	Transcutaneous Elect. Nerve Stimulator	Medical Research Laboratories, Inc.			1981-03-20
K802478	Cyber 120 Hemodialyzer	Cyberex Corp.	FJG	Class II	1981-03-20
K810747	Disposable Probe for Aquamatic K-Thermia	American Hamilton			1981-03-19
K810291	Sterile/disposable Hsg Tray	Unimar, Inc.	EYY	Class II	1981-03-18
K810708	Hollister Male Urinary Incont. System	Hollister, Inc.			1981-03-17
K810615	Corning 925 Chloride Meter	Corning Medical & Scientific	JFS	Class II	1981-03-17
K810601	Emit-St Serum Phencyclidine Assay	Syva Co.	LCM	Unclassified	1981-03-17
K810597	Macro-Vue Card Test	BD Becton Dickinson Vacutainer Systems Preanalytic	KLB	Class II	1981-03-17
K810596	Centrifi Chem System 400 Analyzer	Union Carbide Corp.	JJE	Class I	1981-03-17
K810586	Emit-Tfg Prisma Thyroxine Assay	Syva Co.	KLI	Class II	1981-03-17