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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2971 of 3529

510(k) clearances, page 2971 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852859	Pennine Connecting Tubing	Pennine Medical, Ltd.			1985-07-30
K852806	Quidel Quest Strep Group a Test	Ortho-Clinical Diagnostics, Inc.	GTZ	Class I	1985-07-30
K852659	Biogloss	Dentsply Intl.	EBF	Class II	1985-07-30
K852586	Cromic Surgical Microscope Model Mc-1	Seltrex, Corp.	HRM	Class I	1985-07-30
K852477	Kelly-Groerss-Kall CT Sterotactic Adaptation Sys	Mayo Clinic	HAW	Class II	1985-07-30
K852283	Thermix Inc. Nasotherm II Personal Steam Machine	Thermix, Inc.	KFZ	Class I	1985-07-30
K852270	Lifescope 8 Dec-8108A and Dec-8204A	Nihon Kohden America Inc	DSI	Class II	1985-07-30
K852193	Porocoat Schatzker II Acetabulum	Depuy, Inc.	DXQ	Class II	1985-07-30
K852125	Pathfinder Detection & Collection Kits-Herpes Simp	Kallestad Laboratories, Inc.	GQL	Class II	1985-07-30
K852092	Pb900 Pb910 Diagnostic Spirometer	Medtronic, Inc.	BZG	Class II	1985-07-30
K852088	System 1085 Body Plethysmograph	Medical Graphics Corp.	CCM	Class II	1985-07-30
K851843	Osmocel 3	Hematology Marketing Assoc.	GIF	Class I	1985-07-30
K851736	Coulter Channelyzer 256	Coulter Electronics, Inc.	GKL	Class II	1985-07-30
K851636	Diamat Glycoslated Hemoglobin Analyzer System	Bio-Rad	LCP	Class II	1985-07-30
K851566	Howmedica Femoral Component Hip Sys 6259	Howmedica Corp.	JDG	Class II	1985-07-30
K850342	Wyler Subdural Strip Electrode	AD-Tech Medical Instrument Corp.	GYC	Class II	1985-07-30
K845035	Electrode for Neurological Surgery 2111	Progress Mankind Technology	GYC	Class II	1985-07-30
K844818	Normalized Hs3n Proportional Series Hip Stems	Osteonics Corp.	KWL	Class II	1985-07-30
K853015	Self-Centering Bone Holding Forceps, 10-1/4 Ss420	The Huxley Instrument Corp.	GEN	Class I	1985-07-29
K852994	Reichert Flexible Laryngoscope, Model Ls-11	Reichert-Jung, Inc.	CAL	Class I	1985-07-29
K852964	P.c.a. Total Hip Femoral Component Modification	Howmedica Corp.	DXQ	Class II	1985-07-29
K852957	Sahara Sunbed	Sahara Sun Beds., Inc.	FTC	Class II	1985-07-29
K852945	Huck Towel	South Mountain Medical	KKX	Class II	1985-07-29
K852918	Slim Art J. Bip Pacing Lead Using Poly #030-2821	Telectronics, Inc.	DYB	Class II	1985-07-29
K852917	Slim Art/j-Svc Ind Pacing Lead Using Poly #30-283	Telectronics, Inc.	DYB	Class II	1985-07-29
K852916	Slim Vent Bipo Pacing Lead Using A90 Insul,#30-284	Telectronics, Inc.	DYB	Class II	1985-07-29
K852915	Slim Vent Unipo Pacing Lead Using Polyu 90A,30-281	Telectronics, Inc.	DTB	Class III	1985-07-29
K852821	Disposable Vvc(volume Ventilator Circuit)	Medtronic, Inc.	BZD	Class II	1985-07-29
K852818	Sterile Disposable Syringes(2 Pieces)	Fabersanitas, S.A.	FMF	Class II	1985-07-29
K852798	Fiberlase 100 Medical Laser System	Laser Media	LNK	Class II	1985-07-29
K852678	Capd Transfer Set for Reduced Fill Volumes 5C4353	Travenol Laboratories, S.A.	KDJ	Class II	1985-07-29
K852605	Blood Tubing Set	Medflex International, Inc.	FJK	Class II	1985-07-29
K852412	Non-Adherent Pad	American White Cross, Inc.	EFQ	Unclassified	1985-07-29
K852408	Extra Large Adhesive Strips	American White Cross, Inc.	KGX	Class I	1985-07-29
K852354	Wholey Hi-Torque Guide Wires	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1985-07-29
K852253	329 Cordis Encor Prevenous Artrial & Ventricular	Cordis US Corp.	DTD	Class II	1985-07-29
K852146	Quidel Quest Ovulation Test	Ortho-Clinical Diagnostics, Inc.	CEP	Class I	1985-07-29
K852024	Dentin Adhesive	Dentsply Intl.			1985-07-29
K851965	Wilson-Cook Stone Extractor	Wilson-Cook Medical Inc.	FFL	Class II	1985-07-29
K851960	Soehendra Biliary Dilating Catheter-Sbdc-7	Wilson-Cook Medical Inc.	FGE	Class II	1985-07-29
K851702	Mortara Instrument Model El-1	Mortara Instrument, Inc.	DSI	Class II	1985-07-29
K851616	3.5. Mhz Probe for Ausonics 150 & 357 Real Time Ca	Ausonics Pty, Ltd.	JOP	Class II	1985-07-29
K851445	Color Ovulation Test	Nms Pharmaceuticals, Inc.	CEP	Class I	1985-07-29
K851439	Mobilaire, Pla-01 Oxygen Concentrator	Invacare GmbH	CAW	Class II	1985-07-29
K851438	Mobilaire Ii(p2a) Oxygen Concentrator	Invacare GmbH	CAW	Class II	1985-07-29
K851437	Prime Aire O2 Plus 2	Invacare GmbH	CAW	Class II	1985-07-29
K851435	Prime Aire O, Model Pa02 2 O Oxygen Concentrator	Invacare GmbH	CAW	Class II	1985-07-29
K851434	Mobilaire III P3 Oxygen Concentrator	Invacare GmbH	CAW	Class II	1985-07-29
K851269	Doplette 10	Imex Medical Systems, Inc.	JOP	Class II	1985-07-29
K851237	Thermophore Electric Fomentation Unit	Battle Creek Equipment	IRT	Class II	1985-07-29