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 3467 of 3526

510(k) clearances, page 3467 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772112	Non-Fermenter System	Corning Medical & Scientific	JSW	Class I	1977-11-17
K772108	In Vitro T3 Ria Test	Clinical Assays, Inc.	CDP	Class II	1977-11-17
K772035	Gemsaec Appli. for Ultrazyme Plus Y-Amyl	Harleco	JFJ	Class II	1977-11-17
K772034	Gemsaec Appli. for Ultrazyme Plus Ck-1	Harleco			1977-11-17
K772033	Gemsaec Appli. for Ultrazyme Plus Alp*	Harleco	JMK	Class I	1977-11-17
K772032	Gemsaec Appli. for Ultrazyme Plus Alp	Harleco	CJE	Class II	1977-11-17
K771979	Centria Insulin Ria	Union Carbide Corp.	CFP	Class I	1977-11-17
K771867	Mycoplasma Detection Kit	Bioassay Systems Research Corp.	KPB	Class I	1977-11-17
K771810	Pressure Tubing	Pharmaseal Div., Baxter Healthcare Corp.	DQO	Class II	1977-11-17
K770937	Pump, Bypass, Pulsatile, Avco	Avco Medical Products	KFM	Class II	1977-11-17
K772124	Lenses, Eyeglass, Safety	Techsight Corp.	HQG	Class I	1977-11-16
K772113	Urinary Drainage Bag 2D9017	Travenol Laboratories, S.A.	EYZ	Class I	1977-11-16
K772036	In-Line Burette Set	Abbott Medical	FPA	Class II	1977-11-16
K771929	Pediatrics Gown	Convertors	FYB	Class II	1977-11-16
K772072	Manifold & Nebu. for Doub. Line Mach.	Inspiron Corp.	CAF	Class II	1977-11-15
K772071	Manifold & Nebu. for Single Line Mach.	Inspiron Corp.	CAF	Class II	1977-11-15
K772070	Ventilator Setup, Volume	Inspiron Corp.	CAF	Class II	1977-11-15
K772069	Vol. Ventilator Setup W/out Nebulizer	Inspiron Corp.	BZO	Class I	1977-11-15
K772068	Manifold & Nebulizer, Universal	Inspiron Corp.	CAF	Class II	1977-11-15
K772062	Neonatal Flotation System	Medpro, Inc.	IKY	Class I	1977-11-15
K772059	Catheter, Pacing/monitoring	Electro-Catheter Corp.	DYG	Class II	1977-11-15
K772055	Pentax F.o.-It Observer Scope	Pilling Co.			1977-11-15
K772029	Gemsaec Appli, for Ultrazyme Plus Got	Harleco	CIT	Class II	1977-11-15
K772028	Gemsaec Appli. for Ultrazyme Plus Ldh	Harleco	CFJ	Class II	1977-11-15
K772015	Patient Heater System, Model Ph112	Carolina Medical Electronics	DWJ	Class II	1977-11-15
K771999	Electrotherm Models F&c18,14,78, F84	Electromedics, Inc.	FLL	Class II	1977-11-15
K771998	Temp-a-Lert Model Ta-986	Electromedics, Inc.	FLL	Class II	1977-11-15
K771997	Telethermometer Model T T-400	Electromedics, Inc.	FLL	Class II	1977-11-15
K771989	Continuous Flow Anesthesia Machine	Draeger, Inc.	BSZ	Class II	1977-11-15
K771921	Hydron Root Canal Filling System	National Patent Development Corp.	KIF	Class II	1977-11-15
K771913	Heel/elbow Protector	Alba-Waldensian, Inc.	FMP	Class I	1977-11-15
K771619	Proximate Disp. Skin Stapler	Ethicon, Inc	GAG	Class II	1977-11-15
K772119	Time Watch	Akzona, Inc.	FPK	Class II	1977-11-14
K772087	Ultrasonic Denture Cleaner	Clairol, Inc.	EFT	Class I	1977-11-14
K772064	Thyrodot-4 Antisera Lyopholized	Medcom Diagnostics, Inc.	CDX	Class II	1977-11-14
K772031	Gemsaec Appli. for Ultrazyme Plus Y-Gt	Harleco			1977-11-14
K772030	Gemsaec Appli. for Ultrazyme Plus Gpt	Harleco	CKA	Class I	1977-11-14
K771928	Calcium Set, Item No. 65004	Harleco	CJY	Class II	1977-11-14
K771927	Iron Set, Item No. 65008	Harleco	JMO	Class I	1977-11-14
K771887	Accu-Stain	Williams Gold Refining Co., Inc.	EIH	Class II	1977-11-14
K771886	Accu-Paque	Williams Gold Refining Co., Inc.	EIH	Class II	1977-11-14
K771795	Las-R Ceruloplasmin Test	Hyland Therapeutic Div., Travenol Laboratories	DDB	Class II	1977-11-14
K772089	Laparotomy Spogne	General Medical Co.	EFQ	Unclassified	1977-11-11
K772081	Nail, Intramedullary, Flexible	Depuy, Inc.	HSB	Class II	1977-11-11
K772049	Walking Aid	Guardian Products Co., Inc.	ITJ	Class I	1977-11-11
K772025	Uric Acid Std. for Quant. Uric Acid	Worthington Biochemical Corp.	JIS	Class II	1977-11-11
K772022	Spectrophotometer Cary 219	Varian Assoc., Inc.	JJQ	Class I	1977-11-11
K771926	Total Protein Set, Item No. 64010	Harleco	CEK	Class II	1977-11-11
K771923	Fastchem Bun	Boehringer Mannheim Corp.	CDQ	Class II	1977-11-11
K771700	Tma Bicarbonate/glycerol Diluent	Hyland Therapeutic Div., Travenol Laboratories			1977-11-11