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 2183 of 3531

510(k) clearances, page 2183 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920579	Low Profile Passport Push & Pull Kits & Peg Tube	Wilson-Cook Medical Inc.	KNT	Class II	1994-07-08
K942641	Surgin Irrigation Pump	Surgin Surgical Instrumentation, Inc.	GCJ	Class II	1994-07-07
K942639	Biopsy Needle and Housing	Biopsys Medical, Inc.	KNW	Class II	1994-07-07
K942491	Origin Balloon Retractor	Origin Medsystems, Inc.	GCJ	Class II	1994-07-07
K942372	Simulvue 38 (Polymacon) Soft (Hydrophilic) Bifocal Contact Lens	Unilens Corp., USA	LPL	Class II	1994-07-07
K942205	Zebra Urological Guidewire	Boston Scientific Corporation	KNY	Class II	1994-07-07
K942010	Vascu-Guard	Bio-Vascular, Inc.	DXZ	Class II	1994-07-07
K941836	Unilens 38 Soft Aspheric Contact Lens	Unilens Corp., USA	LPL	Class II	1994-07-07
K941249	Specimen Removal Device	General Surgical Innovations	GCJ	Class II	1994-07-07
K941151	Stratofuse Pca II Infuser	Infusion Technology Intl.	FRN	Class II	1994-07-07
K935719	Dail a Hearing Screening Test	Occupational Hearing Services	EWO	Class II	1994-07-07
K935659	Baxter Night Exch Device(nxd) Peritoneal Dialy Syst	Baxter Healthcare Corporation	FKX	Class II	1994-07-07
K934333	3M Red Dot 2237 Sticky Gel Monitoring ECG Electrode	3M Medical Products Group	DRX	Class II	1994-07-07
K932984	Unlubricated Condom, Essentials, Mi Vida & Jiffi	Sime Health, Ltd.	HIS	Class II	1994-07-07
K932983	Colored Condoms (Essentials, Mi Vida, Jiffi)	Sime Health, Ltd.	HIS	Class II	1994-07-07
K932982	Spermicidal Lubric. Condoms (Essentials, Mi Vida, Jiffi)	Sime Health, Ltd.	HIS	Class II	1994-07-07
K931720	Lundia Alpha 700 Hemodialyzer	C.G.H. Medical, Inc.	KDI	Class II	1994-07-07
K922455	Evert-O-Cath Catheter	American Biomaterials Corp.	DQO	Class II	1994-07-07
K942736	Carbomedics(r) Prosthetic Heart Valve Holder Handle	Carbomedics, Inc.	DTJ	Class I	1994-07-06
K942672	Steri-Lube	Petroleum Products of America	EFB	Class I	1994-07-06
K942607	Laparoscopic Scissors (Disposable)	O.R. Specialties, Inc.	GEI	Class II	1994-07-06
K942246	Puritan-Bennett Nasal CPAP Mask	Medtronic, Inc.	BYE	Class II	1994-07-06
K942182	Megabeam Dental Fiber	Ceram Optec, Inc.	GEX	Class II	1994-07-06
K942172	Influenza a Antigen Test	Neogenex	GNW	Class I	1994-07-06
K942017	V-Primer	Parkell, Inc.	KLE	Class II	1994-07-06
K941785	Sunglasses	K. L. Wings Co., Ltd.	HQY	Class I	1994-07-06
K941771	Bodywise Pregnancey Test	Charlton Assoc.	LCX	Class II	1994-07-06
K941721	Emc Model No. 322870 Endostat	Emc Industries	GEI	Class II	1994-07-06
K941603	Amo Phacoflex Inserter Disposable Cartridge, and Handpiece	Advanced Medical Optics, Inc.	KYB	Class I	1994-07-06
K941584	Creatine Kinase Method	Dupont Medical Products	JHS	Class II	1994-07-06
K941440	Cobas-Fp Quinidine Reagents and Calibrators	Roche Diagnostic Systems, Inc.	LBZ	Class II	1994-07-06
K941428	Exacta Percutaneous Introducer Sheath	GE Healthcare	DYB	Class II	1994-07-06
K941355	Pregnancy Check	SA Scientific, Ltd	LCX	Class II	1994-07-06
K940935	Urine Calibrator	Diagnostic Reagents, Inc.	DKB	Class II	1994-07-06
K940647	Orbscan(tm) Keratometer	Orbtek, Inc.	HLQ	Class I	1994-07-06
K940567	Model#1550 Marsona(r) Tinnitus Masker	Marpac, Inc.	KLW	Class II	1994-07-06
K936112	Strep B Oia	Biostar, Inc.	GTY	Class I	1994-07-06
K936051	Omni-Central Station Monitor	Invivo Research, Inc.	DRT	Class II	1994-07-06
K934498	Doa Liquid Drugs of Abuse Controls	Medical Analysis Systems, Inc.	DIF	Class I	1994-07-06
K934457	Stability Hip Stem with Porocoat	Depuy, Inc.	LZO	Class II	1994-07-06
K934293	Beckman Pancreatic Amylase (Pamy) Reagent	Beckman-Diagnostic Systems Group	JFJ	Class II	1994-07-06
K932892	Passive Plus Endocardial Pacing Leads Var. Models	Siemens-Pacesetter, Inc.	DTB	Class III	1994-07-06
K932093	Autovac Closed Wound Autotransfusion System,7920 S	Boehringer Laboratories, LLC	CAC	Class II	1994-07-06
K930047	Dsl Igfbp-3 Ria (Dsl 6700)	Diagnostic Systems Laboratories, Inc.	CFL	Class I	1994-07-06
K922106	Alice	Healthdyne, Inc.	OLV	Class II	1994-07-06
K942594	Star 42 Pp Sp Star 42 Digitally Programmable Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1994-07-05
K942576	Clear Lens Endoscopic Fog Reduction Device	White Knight Healthcare	OCT	Class II	1994-07-05
K942493	Scotchbond Multi-Purpose Plus Dental Adhesive System	3M Company	KLE	Class II	1994-07-05
K942040	Mrx-280	Mrx Corp.	JAK	Class II	1994-07-05
K941899	Sdi Composties	Southern Dental Industries, Inc.	EBF	Class II	1994-07-05