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 3282 of 3528

510(k) clearances, page 3282 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K811759	Retracting Probes	American V. Mueller	GAD	Class I	1981-07-20
K811754	Crystona	Smith & Nephew, Inc.	ITG	Class I	1981-07-20
K811750	Multitubular Thoracic Air Splints	Roger Cestac & Assoc.	IPT	Class I	1981-07-20
K811738	Collarless Tapered Stem Hip Prosth. Dev	Zimmer GmbH	KWL	Class II	1981-07-20
K811728	Castle & Ritter Minor Surg. & Exam Lt	Sybron Corp.	FTD	Class II	1981-07-20
K811723	Whole Body Scanner	Cgr Medical Corp.	JAK	Class II	1981-07-20
K811717	Gator Drapes	The Anspach Effort, Inc.	KQM	Class I	1981-07-20
K811715	Rota Camera	Siemens Gammasonics, Inc.	IYX	Class I	1981-07-20
K811712	Tip Wipe	Devon Industries, Inc.	KDC	Class I	1981-07-20
K811707	Axicut Disposable Scalpel	Neonatal Corp.	GDX	Class I	1981-07-20
K811691	Cordis Omni-Articor Cardiac Pacer #308	Cordis US Corp.	DXY	Class III	1981-07-20
K811686	Surgical Instruments	C.V.I., Inc.	GEN	Class I	1981-07-20
K811631	Thermometer (Made in China)	Robert I. Chien & Assoc., Inc.	FLK	Class II	1981-07-20
K811557	Depuy Hemodrain	Depuy, Inc.	GCY	Class I	1981-07-20
K811391	Oximetrix Accu Sat Cpb	Oximetrix, Inc.	DRY	Class II	1981-07-20
K811318	Temporary Endocardial Tripolar Ld. #6880	Medtronic, Inc.	LDF	Class II	1981-07-20
K811277	Cath-Dap	Northwest Alabama Urological Assoc.	KOD	Class II	1981-07-20
K811217	Pacemaker Programmer #2010	Cardiac Pacemakers, Inc.	KRG	Class III	1981-07-20
K811119	Weber/stuehmer Hip Joint Endoprosthesis	Allo Pro Corp.			1981-07-20
K810887	Ela Medical Unilith 7540 Pulse Generator	Ela Medical, Inc.	DXY	Class III	1981-07-20
K811963	Visitec Needle Range (Anesthesiology)	Visitec Co.	BSP	Class II	1981-07-16
K811909	Cardiopulmunary Resuscitator	Michigan Instruments	DRM	Class II	1981-07-16
K811908	Imv Manifolds	Airlife, Inc.	CBO	Class II	1981-07-16
K811880	Leeco Ferritin-Quant Diag. Test Kit	Leeco Diagnostics, Inc.	DBF	Class II	1981-07-16
K811869	Unscented Menstrual Pads	Procter & Gamble Mfg. Co.	HHD	Class I	1981-07-16
K811868	Scented Menstrual Pads	Procter & Gamble Mfg. Co.	HHL	Class II	1981-07-16
K811861	Arthroscopic Leg Holder	Stryker Corp.	HRX	Class II	1981-07-16
K811860	Easy-Flo Arterial Blood Gas Kit	Dhd Medical Products Div. Diemolding Corp.	CBT	Class I	1981-07-16
K811858	Khi Cpram Breathing Circuit	Khi, Inc.	CAI	Class I	1981-07-16
K811854	Galactosid-Ase Tubes	Microchemical Specialities, Co.	JTO	Class I	1981-07-16
K811853	Pholphoryl-Ase Tubes	Microchemical Specialities, Co.	JTO	Class I	1981-07-16
K811852	Reduct-Ase Tubes	Microchemical Specialities, Co.	JSH	Class I	1981-07-16
K811743	Maxitherm	Cincinnati Sub-Zero	DWJ	Class II	1981-07-16
K811740	Kallestad's Endoplate Factor B Test	Kallestad Laboratories, Inc.	JZH	Class II	1981-07-16
K811721	H-101 Kappa,h-102 Lambda,h-107 Lysozme	Immulok, Inc.	DFH	Class II	1981-07-16
K811702	Model 381 Home Oxygen Sentry	Stanley Aviation Corp.	CCL	Class II	1981-07-16
K811660	Playtex Modified Fiber Tampons	Playtex, Inc.	HIL	Class II	1981-07-16
K811589	Actin Fs Activated Ptt Reagent	American Dade	GGW	Class II	1981-07-16
K811568	Cervical Dilator	Gynemetrics, Inc.	HDQ	Class I	1981-07-16
K811562	Toxoplasmosis Test Kit	Immuno-Diagnostic Products, Inc.	GLZ	Class II	1981-07-16
K811341	Biovision Cardiac Strobe	Cardiac Imaging	DPS	Class II	1981-07-16
K811117	Eye Care Tray	American Pharmaseal Div. Ahsc			1981-07-16
K811109	Thrombin Clotting Time	Bio/Data Corp.	GJA	Class II	1981-07-16
K810940	The Beta	Burdick Corp.	DSI	Class II	1981-07-16
K810569	Contact-Micro Colpohysteroscope	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1981-07-16
K810115	Dopplex-Plb & Pxb	Huntleigh Technology, Inc.	KNG	Class II	1981-07-16
K811952	Ames Tda Carbamazepine Test	Miles Laboratories, Inc.	KLT	Class II	1981-07-15
K811890	Disposable Trach T Oxygenator	Airlife, Inc.	BZA	Class I	1981-07-15
K811849	Eskaflow Test for Glucose	Smithkline Diagnostics, Inc.	CFR	Class II	1981-07-15
K811840	Bilirubinometer	Advanced Instruments, LLC	JJQ	Class I	1981-07-15