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 3354 of 3526

510(k) clearances, page 3354 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801006	Charnley Design Hip Prosthesis	Colmed, Ltd.	JDG	Class II	1980-05-20
K800953	Fixomull Sterile	Beiersdorf, Inc.	NAD	Class I	1980-05-20
K800934	R2 Esu Cable-Adapter Models 160,161	R2 Corp.	IKD	Class II	1980-05-20
K800933	R2 Electrosurg. Return Elect. #225Etc.	R2 Corp.	JOT	Class II	1980-05-20
K800929	White Knight Surgical Pack	G.D. Searle and Co.	FYA	Class II	1980-05-20
K800928	White Knight Supplemental Drape	G.D. Searle and Co.	KKX	Class II	1980-05-20
K800927	White Knight Disp. Sterile Back Gown	G.D. Searle and Co.	FYA	Class II	1980-05-20
K800907	Tomac Wet Dressing Warmer	W.G. Whitney Corp.	KGX	Class I	1980-05-20
K800901	Kodak Ektaspeed Dental X-Ray Film	Eastman Kodak Company	IWZ	Class I	1980-05-20
K800832	Viral Culturette Hank's Bal. Salt Sol.	Marion Health & Safety, Inc.	JSM	Class I	1980-05-20
K800810	Flare Dis. Nonwoven Head Covers	Flare Products, Inc.	FYF	Class I	1980-05-20
K800809	Flare Dis. Conductive&non. Shoe Covers	Flare Products, Inc.	FXP	Class I	1980-05-20
K800771	Mod. Dm-356 Ips Interface Module	Extracorporeal Medical Specialities, Inc.	FKQ	Class II	1980-05-20
K800575	Vacudent Lumix 70	Vacudent Sales Corp.	EHP	Class I	1980-05-20
K800574	Vacudent Lumix 65	Vacudent Sales Corp.	EHP	Class I	1980-05-20
K800285	Model 5985 Pacemaker Pulse Generator	Medtronic, Inc.	DXY	Class III	1980-05-20
K801112	Empi Model 910S, TENS	Empi	GZJ	Class II	1980-05-14
K801081	Deluxe Heat Wrap/cold Wrap	The Gillette Company	IRT	Class II	1980-05-14
K801064	Disposable Patient Cable Model 5807	Daig Corp.	DSA	Class II	1980-05-14
K801050	Supra Scope	Warner-Lambert Co.	BZS	Class I	1980-05-14
K801048	Accudynamic	Sorensen Research	DRS	Class II	1980-05-14
K801046	Anaton	Armkel, LLC	DHN	Class II	1980-05-14
K801018	Immulon 1, #11-010-3350 & Immulon 2 #--	Dynatech Laboratories, Inc.			1980-05-14
K801015	Prezapak L Arterial Blood Sampling Kit	Kimble-Terumo, Inc.	GIM	Class II	1980-05-14
K801012	Triglyceride Reagent (Color)	Gilford Diagnostics	JGY	Class I	1980-05-14
K801007	Il System 502 Na/k Analyzer	Instrumentation Laboratory Co.	JGS	Class II	1980-05-14
K800996	Hdl Reagent	Gilford Diagnostics	LBR	Class I	1980-05-14
K800995	Immunoglobulin E Test Kit	Calbiochem-Behring Corp.	DGO	Class II	1980-05-14
K800961	Enema Container Disp. for Emema Admin.	The Healthcare Group Laboratories, Inc.	FCE	Class I	1980-05-14
K800960	1500 Ml Disposable Enema Container(1110)	The Healthcare Group Laboratories, Inc.	FCE	Class I	1980-05-14
K800959	Large Volume Enema Container Disposable	The Healthcare Group Laboratories, Inc.	FCE	Class I	1980-05-14
K800952	Paper-Pak Ob Pads	Paper-Pak Products, Inc.	HHD	Class I	1980-05-14
K800922	Nordiclab Progesterone Ria Test	Nordiclab Intl.	JLS	Class I	1980-05-14
K800921	Nordiclab Testosterone Ria Test	Nordiclab Intl.	CDZ	Class I	1980-05-14
K800920	Nordiclab Estradiol Ria Test	Nordiclab Intl.	CHP	Class I	1980-05-14
K800913	Gynecological Cysto/urethroscope	Kli	FGC	Class II	1980-05-14
K800892	Nuclear Stress Table (Nst-1)	Technicare Corp.	ISD	Class II	1980-05-14
K800880	Plastic Tubing Adapters 5-in-1-	Harvard Laboratories	DTL	Class II	1980-05-14
K800859	Fetal Heart Detector #D206	Sonicaid, Inc.	KNG	Class II	1980-05-14
K800858	Fetal Heart Detector #'S D102 & D102r	Sonicaid, Inc.	KNG	Class II	1980-05-14
K800833	Vabra Aspirator	Cooper Medical Devices Corp.	HHI	Class II	1980-05-14
K800825	Extension Set Quest Code #3000	Quest Medical, Inc	FPK	Class II	1980-05-14
K800824	Model Ski-200 Abdominal Scanner	Smithkline Diagnostics, Inc.	IYO	Class II	1980-05-14
K800792	Adjustable Head & Face Holder	Radiation Products Design, Inc.	IYE	Class II	1980-05-14
K800791	Mylar Window-Table Insert Panel	Radiation Products Design, Inc.	IYE	Class II	1980-05-14
K800790	Tennis Racket-Table Insert Panel	Radiation Products Design, Inc.	IYE	Class II	1980-05-14
K800788	Siregraph C	Siemens Medical Solutions USA, Inc.	KPR	Class II	1980-05-14
K800777	Tampax Tampons	Tampax, Inc.	HEB	Class II	1980-05-14
K800772	Mod. Dm-357 Bicarbonate Retrofit Kit	Extracorporeal Medical Specialities, Inc.	FKR	Class II	1980-05-14
K800762	Ps3 Titanium Screw Dental Implant	Colmed, Ltd.	DZE	Class II	1980-05-14