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 2026-11-05, 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 2353 of 3531

510(k) clearances, page 2353 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923049	Uroskop D1, Uroskop D2, and Uroskop D3	Siemens Medical Solutions USA, Inc.	OWB	Class II	1992-09-15
K923040	Miles Urine Glucose Method	Kulzer GmbH	CFR	Class II	1992-09-15
K923034	Miles Urine Calcium Method	Kulzer GmbH	CIC	Class II	1992-09-15
K923030	Ani Biocard Hcg Test	Ani Oy	JHI	Class II	1992-09-15
K923024	Ne-U04/ne U04f	Omron Healthcare Co., Ltd.	CAF	Class II	1992-09-15
K922923	Ne-U07	Omron Healthcare Co., Ltd.	CAF	Class II	1992-09-15
K922897	Strappal	Smith & Nephew United, Inc.	KGX	Class I	1992-09-15
K922895	J-Vac Bulb Suction Reservoir	Johnson & Johnson MEDICAL GmbH	GCY	Class I	1992-09-15
K922888	One Touch Iib Blood Glucose Meter	Lifescan, Inc.	CGA	Class II	1992-09-15
K922272	Yasargil Aneurysm Clips	Aesculap Inc	HCH	Class II	1992-09-15
K922262	Sporicidin Brand Disinfect Towelettes/spray/solut	Sporicidin Intl.	LRJ	Class I	1992-09-15
K921698	Cn Endotracheal Tube Holder	N-C-N Products Co.	CBH	Class I	1992-09-15
K921500	Centri-Safe(tm) Valve	Cardio Systems, Inc.	MJJ	Class II	1992-09-15
K920889	Minimax(r)/maxima(r) Hollow Fiber Oxygenators	Medtronic, Inc.	DTZ	Class II	1992-09-15
K920353	Ultracell Instrument Wipe	Ultracell Medical Technologies, Inc.	HEP	Class II	1992-09-15
K914488	Models: Ircrf5, Ircpf16 Flowmeter Accessory Kits	Invacare GmbH	CAW	Class II	1992-09-15
K923397	Single Dose Gas Injector	Escalon Medical Trek	BXX	Class I	1992-09-14
K923386	Thc Urine Calibrators	Diagnostic Reagents, Inc.	DLJ	Class II	1992-09-14
K923351	Skin Support Prep Pad	MEDLINE INDUSTRIES, LP - Northfield	KOX	Class I	1992-09-14
K923097	Uresil Nephrostomy Catheter	Uresil, LLC	LJE	Unclassified	1992-09-14
K922957	Paragon	Jeneric/Pentron, Inc.	EJS	Class II	1992-09-14
K922956	Kb40-Kf	Jeneric/Pentron, Inc.	EJS	Class II	1992-09-14
K922937	Flexible Fiber Optic Endoscope	Optimed Technologies, Inc.	EOQ	Class II	1992-09-14
K922798	Qd Whole Body Coil, Mrt-150A	Toshiba America Mri, Inc.	LNH	Class II	1992-09-14
K921628	Epstein-Barr Vir Early Anti Diff Igg Clin-Elisa	Incstar Corp.	LSE	Class I	1992-09-14
K921523	Opus(r) Toxo-G Test System	Pb Diagnostics, Inc.	LGD	Class II	1992-09-14
K921228	Benderev Protect-a-Pass Needle	Eimark Labs, Inc.	KOA	Class I	1992-09-14
K920510	Uresil Locking General Purpose Drainage Catheter	Uresil, LLC	GAR	Class II	1992-09-14
K920509	Uresil Sump Drainage Catheter	Uresil, LLC	LJE	Unclassified	1992-09-14
K920087	Ige Eia Test Kit	The Binding Site	DGO	Class II	1992-09-14
K915100	Brindley & Smith Et-1000	Zmi Corp.	LIH	Class II	1992-09-14
K914685	866.5750 Radioallergosorbent Immunlogical Test Sys	In Vitro Technologies, Inc.	DHB	Class II	1992-09-14
K924264	O.r. Concepts Cable Harness	O.R. Concepts, Inc.	GEI	Class II	1992-09-11
K923846	Burn Dressing	Medical Action Industries, Inc. 306	NAB	Class I	1992-09-11
K923445	Pyloragen Helicbacter Pylori Test Kit - Modified	Hycor Biomedical	LYR	Class I	1992-09-11
K923322	Trace Albumin-Mr Reagent	Trace Scientific, Ltd.	CIX	Class II	1992-09-11
K923270	Kodak Ektascan Imagelink Quality Control Workstati	Eastman Kodak Company	LLZ	Class II	1992-09-11
K923237	Technicon H*2	Kulzer GmbH	GKZ	Class II	1992-09-11
K923236	Triad Inlay Composite	Dentsply Intl.	EBF	Class II	1992-09-11
K923106	Scan Band	Cook, Inc.	JAK	Class II	1992-09-11
K922959	Isopore Tape	Lectec Corp.	KGX	Class I	1992-09-11
K922874	Dispsable Forceps, Hemostats, Probes, Needle Guide	Supra Instruments, Inc.	MDM	Class I	1992-09-11
K922814	Tec1410 Anatomical Programming Generator-Modificat	Bay Shore Medical Equipment, LLC	IZO	Class I	1992-09-11
K922675	Prospect Giardia Controls	Alexon, Inc.	MHI	Class II	1992-09-11
K922588	Roche Enterotube II	Roche Diagnostic Systems, Inc.	JSS	Class I	1992-09-11
K922560	Consensus(tm) Bipolar System	U.S. Medical Products, Inc.	KWY	Class II	1992-09-11
K922483	Du Pont Compact Daylight System 2000	E.I. Dupont de Nemours & Co., Inc.	KPX	Class II	1992-09-11
K922454	Mobile Athena HF	Fischer Imaging Corp.	IZH	Class II	1992-09-11
K922388	Waters(tm) Lc Module I for Clinical Use	EMD Millipore Corporation	LDM	Class I	1992-09-11
K921963	Disposable, Filtered Insufflation Tubing, 92-900	Sun Medical Co., Ltd.	HIF	Class II	1992-09-11