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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2440 of 3531

510(k) clearances, page 2440 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K912237	Stryker Eclipse Warming Stretcher	Stryker Medical	DWI	Class I	1991-07-30
K912199	Softtouch(r) Guiding Catheter	Mallinckrodt Medical	DQY	Class II	1991-07-30
K912195	Pa-396 Gold Based/precious Metal Alloys Clin Use	Jelenko Co.	EJS	Class II	1991-07-30
K912194	Pa-393 Gold Based/precious Metal Alloys Clin Use	Jelenko Co.	EJS	Class II	1991-07-30
K912191	Softouch(r) Guiding Catheter W/bumper Tip	Mallinckrodt Medical	DQY	Class II	1991-07-30
K912136	Cholestech Lipid Monitoring Sys.	Cholestech Corp.	CHH	Class I	1991-07-30
K912084	Medtronic Cardiocare Memorytrace Er Model 4221	Medtronic, Inc.	DXH	Class II	1991-07-30
K912076	Poly Braided Pigtail/perc Card Cath W/var Tip Conf	The R Group	DQO	Class II	1991-07-30
K912051	Medi-Therm (Mta-5900) & Detachable Hoses	Gaymar Industries, Inc.	DWJ	Class II	1991-07-30
K911989	Gold Cup EEG Cutaneous Electrode W/lead and Ext.	Somnitec, Inc.	GXY	Class II	1991-07-30
K911958	Cytoclone a & B Eia	Cambridge Biotech Corp.	LLH	Class I	1991-07-30
K911302	Models 5866-24M/5866-38M/5866-40M/6986m Adapt Kit	Medtronic, Inc.	DTD	Class II	1991-07-30
K910852	507 Non-Invasive Vital Signs Monitor	Criticare Systems, Inc.	DRT	Class II	1991-07-30
K910608	Permanent Implantable Fh Endocardial Leads W/tip	BIOTRONIK AG	DTB	Class III	1991-07-30
K910482	Alta Channel Plate Connector	Howmedica Corp.	HRS	Class II	1991-07-30
K904294	Qsi 9500	Quantified Signal Imaging, Inc.	OLU	Class II	1991-07-30
K911922	Bronchoscope Accessory, Nsn 6515-00-315-2200	Delta Industries, Inc.	EOQ	Class II	1991-07-29
K903963	Kits and Trays for One Time Use Only	Apk Technology Co., Ltd	LRP	Class I	1991-07-29
K903962	Instruments for One Time Use/ Disposable	Apk Technology Co., Ltd	LRP	Class I	1991-07-29
K913024	Abbott Quickstart Gamma-Glutamytransferase Test	Em Diagnostic Systems, Inc.	JQB	Class I	1991-07-26
K912980	Monoscopy Brand 5Mm Lock Trocar Sleeve, Modified	Dexide, Inc.	GCJ	Class II	1991-07-26
K912959	Microtrak Manager	Syva Co.	JJQ	Class I	1991-07-26
K912834	Shur-Grip	Inman Medical Corp.	KDC	Class I	1991-07-26
K912826	Whole Blood Alcohol Control, Level 1 & 2	Cala Diagnostics	DKC	Class I	1991-07-26
K912825	Magnesium Assay Kit, Cat.# 100-12	Diagnostic Chemicals, Ltd. (USA)	JGJ	Class I	1991-07-26
K912817	Somnimic (R)	Somnitec, Inc.	LEL	Class II	1991-07-26
K912758	Abuscreen Online for Amphetamines	Roche Diagnostic Systems, Inc.	DKZ	Class II	1991-07-26
K912757	Abuscreen Radioimmunoassay for Cannabiniods	Roche Diagnostic Systems, Inc.	LDJ	Class II	1991-07-26
K912756	Abuscreen Radioimmunoassay for Cocaine Metabolite	Roche Diagnostic Systems, Inc.	KLN	Class II	1991-07-26
K912579	The Voss Disposable Suction/irrigation Cannula	Voss Products	GCJ	Class II	1991-07-26
K912545	Model 4205 Pulse Generator Surgical Exten Cable	Pace Medical	DXY	Class III	1991-07-26
K912520	3M Water Dispersible Adhesive Tape, 98Xx	3M Company	KGX	Class I	1991-07-26
K912427	Multichannel Recording System	Bionique	DSH	Class II	1991-07-26
K912336	Artema Aqua+ Flex	Artema Medical AB	BYD	Class I	1991-07-26
K912335	Artema Aqua+ N	Artema Medical AB	BYD	Class I	1991-07-26
K912334	Artema Aqua+ T & Ts	Artema Medical AB	BYD	Class I	1991-07-26
K912333	Artema Aqua+	Artema Medical AB	BYD	Class I	1991-07-26
K912254	Cox Diaposable Polypectomy Snare	Cox Medical Ent., Inc.	FDI	Class II	1991-07-26
K912146	Ureteral Catheter Holder	Inman Liebelt Corp.	KNY	Class II	1991-07-26
K912143	Cedia(r) Tobramycin Assay	Microgenics Corporation	LFW	Class II	1991-07-26
K912048	Abuscreen(r) Online(tm) Thc Calibrators	Roche Diagnostic Systems, Inc.	DLJ	Class II	1991-07-26
K912036	Robotic Sample Processor	Tecan U.S.	JQW	Class I	1991-07-26
K911998	Multitome Model 1000, Vitrectomy Driving System	Advanced Medical Optics, Inc.	HQE	Class II	1991-07-26
K911982	Bone Nail, Kuntscher	International Hospital Supply Co.	HSD	Class II	1991-07-26
K911919	Minivage(r)	Autovage	KDH	Class II	1991-07-26
K911904	Models Ues-10 & Psd-10	Olympus Corp.	GEI	Class II	1991-07-26
K911901	Maxi Cabinet Optional Built in S6000 Light Source	Stortz	ETF	Class I	1991-07-26
K911890	Osteonics(r) Prt Hip Stem Series	Osteonics Corp.	JDI	Class II	1991-07-26
K911887	Majoli Uterine Manipulator/injector	Cook Ob/Gyn	LKF	Class II	1991-07-26
K911788	Econovage R	Autovage	KDH	Class II	1991-07-26