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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2804 of 3530

510(k) clearances, page 2804 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872388	Nail Set	Med-Tool, Inc.	LRY	Class I	1987-07-23
K871950	Via-Guard	Surgimark, Inc.	JOL	Class II	1987-07-23
K872492	Alternate Suppliers for TENS Electrode	Franklin Sales & Mfg. Co.	GXY	Class II	1987-07-22
K872263	Total Bilirubin Standard Calibrator	FUJIFILM Healthcare Americas Corporation	JIT	Class II	1987-07-22
K871741	Easy Eyes Tm Lens Carrying Case	Eaton Medical Corp.	LRX	Class II	1987-07-22
K871558	Dental Face Masks, Polyester	Carl Parker Associates, Inc.	FXX	Class II	1987-07-22
K871206	Lumenx Model Gat-577 Photocoagu. Pulsed Dye Laser	Phase-R Corp.	GEX	Class II	1987-07-22
K863269	Sonolayer - V, Ssa-100A.	Toshiba Medical Systems	ITX	Class II	1987-07-22
K872746	Vitallium Wire	Austenal Dental, Inc.	EJW	Class I	1987-07-21
K872745	Vinyl Polysiloxane Impression System	Crown Delta Corp.	ELW	Class II	1987-07-21
K872717	Qm300 Haptoglobin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DAD	Class II	1987-07-21
K872714	S.t.a.c.e.m. External Breast Prosthesis Mammary	Roseburg SA	GBI	Class I	1987-07-21
K872661	Rgb Camera System	Aspen Laboratories, Inc.	FWF	Class I	1987-07-21
K872644	Innofluor Vancomycin Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872627	Fsh Serozyme Immunoenzymetric Assay Kit/mag Sep Ph	Serono Diagnostics, Inc.	CGJ	Class I	1987-07-21
K872569	Temrex Etching Gel	Scientific Pharmaceuticals, Inc.	EBF	Class II	1987-07-21
K872560	Anti-Dnp Microassay	Diamedix Corp.	DHN	Class II	1987-07-21
K872550	1.1 Couplers and 1.2 Adapters	Micro-Aire Surgical Instruments, Inc.	HSZ	Class I	1987-07-21
K872511	Chloride for Continuous Flow Instruments	Catachem, Inc.	CHJ	Class II	1987-07-21
K872463	Innofluor(tm) Theophylline Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872462	Innofluor(tm) Gentamicin Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872461	Innofluor(tm) Phenobarbital Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872459	An3100 Mulholland Drain	H.W. Andersen Products, Inc.	GBS	Class I	1987-07-21
K872457	An3500 Worth Drain	H.W. Andersen Products, Inc.	GBS	Class I	1987-07-21
K872449	Nomad (Base Unit/portable Unit)	Minnesota Valley Engineering, Inc.	BYJ	Class II	1987-07-21
K872443	Companion 50 Regulator/flowmeter	Medtronic, Inc.	DRT	Class II	1987-07-21
K872397	Cobas Fp Reagents for Pheno & Cobas Fp Pheno Cali.	Roche Diagnostic Systems, Inc.	LGQ	Class II	1987-07-21
K872354	Series 2000 Bedside Patient Monitor	Marquette Electronics, Inc.	DRT	Class II	1987-07-21
K872349	Innofluor (Tm) Tobramycin Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872286	Ciba Corning Magic Lite Ft4 Immunoassay	Ciba Corning Diagnostics Corp.	CDX	Class II	1987-07-21
K872277	Trakefit Tracheostomy Tube Holder	Ackrad Laboratories	CBH	Class I	1987-07-21
K872270	Orthoconcept Arthroscopic Pump Orthopump	Orthoconcept, Inc.	HRX	Class II	1987-07-21
K872249	Sirecust Model 960 and 961 Patient Monitoring	Medical Electronics Laboratories, Inc.	DRT	Class II	1987-07-21
K872246	Modified Model 9431 Teletrace Transmitter	Medtronic, Inc.	DSH	Class II	1987-07-21
K872244	Cord-Assure Umbilical Blood Gas Kit	Lake Medical Products, Inc.	CBT	Class I	1987-07-21
K872183	Ambulatory EEG Playback	Cadwell Laboratories, Inc.	GWQ	Class II	1987-07-21
K872181	Ethanol Calibrator	American Monitor Corp.	DLJ	Class II	1987-07-21
K872162	Dideco-Shiley Blood Reinfusion Bag	Shiley, Inc.	CAC	Class II	1987-07-21
K872158	Dideco-Shiley Waste Collection Bag	Shiley, Inc.	CAC	Class II	1987-07-21
K872156	Concept Self Compressing Cannulated Screw System	Concept, Inc.	HWC	Class II	1987-07-21
K872142	Innofluor Phenytoin Calibrator Set	Innotron of Oregon, Inc.	DLJ	Class II	1987-07-21
K872060	Washing/injection Needle	Endovations	FBK	Class II	1987-07-21
K872019	Bi-Articular II Hip Device	Zimmer GmbH	KWY	Class II	1987-07-21
K872000	Eye Gard	Treace Medical, Inc.	HOY	Class I	1987-07-21
K871972	Stratus Ige Fluorometric Enzyme Immunoassay	American Dade	DGE	Class II	1987-07-21
K871899	Imperva-a	Shofu Dental Corp.	EBF	Class II	1987-07-21
K871898	Imperva-P	Shofu Dental Corp.	EBF	Class II	1987-07-21
K871870	Hsc Unit Rod	Research Development Corp.	KWP	Class II	1987-07-21
K871843	Two Fluid W/check Valve	Panamedix, Inc.	FPA	Class II	1987-07-21
K871798	Film and Paper Combination Sterilizing Bag	Cost Rite Health Products, Inc.	FRG	Class II	1987-07-21