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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1721 of 3533

510(k) clearances, page 1721 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K993055	Dexide Bipolar Forceps II** Device	United States Surgical, A Division of Tyco Healthc	GEI	Class II	1999-10-05
K992907	Intraducer	Taut, Inc.	GBW	Class I	1999-10-05
K992904	Mini-Port	Taut, Inc.	GBW	Class I	1999-10-05
K992782	Nuvasive Spinal Arthroscope, Models 0, 30 and 70 Degrees	NuVasive Inc	HRX	Class II	1999-10-05
K992714	Micrograsp Monopolar Coagulator, Model Nos 90001-90010	Hysterx, Inc.	GEI	Class II	1999-10-05
K992460	Cautery Clamp and Battery Pack Power Supply	Microline Surgical, Inc	GEI	Class II	1999-10-05
K992442	V.t.s., Inc. (V.t.-3)	Vts, Inc.	LKY	Class II	1999-10-05
K990723	Dyonics Varicose Vein Ablation Blade	Smith & Nephew, Inc.	GEI	Class II	1999-10-05
K990324	Nuvasive Guided Spinal Arthroscopy System	NuVasive Inc	HRX	Class II	1999-10-05
K983793	Preference Treatment System	Northwest Medical Physics Equipment, Inc.	LNH	Class II	1999-10-05
K993132	Genzyme Direct Amylase Verifier	Genzyme Corporation	JIT	Class II	1999-10-04
K993068	Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products Ck-Mb Calibrators	Ortho-Clinical Diagnostics, Inc.	JHX	Class II	1999-10-04
K992466	Ocu-Flex-38 Keratoconus (Polymacon) Soft Contact Lens for Daily Wear	Ocu-Ease Optical Products, Inc.	LPL	Class II	1999-10-04
K992262	Indigo Prostate Seeding Needle Cartridge System	Indigo Medical, Inc.	KXK	Class II	1999-10-04
K992127	Cardioquant Troponin I Test	Spectral Diagnostics, Inc.	MMI	Class II	1999-10-04
K991531	Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078	Cordis Webster, Inc.	DRF	Class II	1999-10-04
K993090	Silhouette Fc	GE Healthcare	KPR	Class II	1999-10-01
K992960	Advanta Graft (>6Mm)	Atrium Medical Corporation	DSY	Class II	1999-10-01
K992958	Advanta Graft (<6Mm)	Atrium Medical Corporation	DYF	Class II	1999-10-01
K992775	Option for the Qdr Bone Densitometer, Models Qdr4500, Qdr2000, Qdr1500, Qdr4000, Qdr1000, Qdr1000w	Hologic, Inc.	KGI	Class II	1999-10-01
K992734	Becton Dickinson Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	MEG	Class II	1999-10-01
K992317	Autospect Plus with Instill Motion Correction	Philips North America LLC	KPS	Class II	1999-10-01
K992292	Gluma Comfort Bond + Desensitizer	Kulzer GmbH	KLE	Class II	1999-10-01
K992276	Modification to Silhouette Spinal Fixation System	Zimmer Spine, Inc.	MNI	Class II	1999-10-01
K992272	Powder-Free Vinyl Patient Examination Gloves	Shanghai Cosmos Corp.	LYZ	Class I	1999-10-01
K992271	Pre-Powdered Vinyl Patient Examination Gloves	Shanghai Cosmos Corp.	LYZ	Class I	1999-10-01
K991965	Purilens System for Cleaning and Disinfecting Contact Lenses	Purilens, Inc.	LYL	Class II	1999-10-01
K990396	T-Anastaflo	Edwards Lifesciences LLC	DWF	Class II	1999-10-01
K990276	Porous Media Dpb30 Series Disposable Pre-Bypass Filter	Pentair Filtration Solutions	KRJ	Class II	1999-10-01
K990992	Integra Reagent Cassette for Hemoglobin Alc	Roche Diagnostics GmbH	LCP	Class II	1999-09-30
K992968	Carto Ep Navigation System	Biosense Webster Inc	DQK	Class II	1999-09-29
K992736	Wallach's Ultimate Reusable, Plastic Vaginal Speculum	CooperSurgical, Inc.	HIB	Class II	1999-09-29
K992728	Spring Powerlite 2000	Spring Health Products, Inc.	EBZ	Class II	1999-09-29
K992622	Intramax Iti Guide Catheter	Intratherapeutics, Inc.	DQY	Class II	1999-09-29
K992378	Diagnostic Ultrasound, Model 1.0	Volumetrics Medical Imaging, Inc.	IYO	Class II	1999-09-29
K992352	Itr2000: Internet Teleradiology, Model Release 1.0	Inteleradiology, Inc.	LMD	Class I	1999-09-29
K992141	Olympus Working Element for Probes	Olympus Winter & Ibe GmbH	FDC	Class II	1999-09-29
K992079	Kendall Model 7325 Scd Response Compression System, Model 7325	Kendall	JOW	Class II	1999-09-29
K991947	3I Ceramic Abutment System	ZimVie US Corp LLC	DZE	Class II	1999-09-29
K991540	Workhorse Percutaneous Transluminal Angioplasty Balloon Catheter	Boston Scientific Corporation	LIT	Class II	1999-09-29
K984415	S.s. White Technologies, Models 6500-D,6500-E, and 6500-F	S.S. White Technologies, Inc.	KOJ	Class II	1999-09-29
K984201	Denzir	Dentronic	EIH	Class II	1999-09-29
K993188	Endostepper 1	Phytron- Elektronik GmbH	EKX	Class I	1999-09-28
K992801	Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast Reagent, Models 51-100P,51-500P,5	Sigma Diagnostics, Inc.	CIT	Class II	1999-09-28
K992800	Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P	Sigma Diagnostics, Inc.	CDQ	Class II	1999-09-28
K992798	Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P	Sigma Diagnostics, Inc.	CDO	Class I	1999-09-28
K992680	Elecsys Parathyroid Hormone Test System	Roche Diagnostics GmbH	CEW	Class II	1999-09-28
K992385	Orthopantomograph Op100d	Instrumentarium Corp.	MUH	Class II	1999-09-28
K990500	Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C	The Kendal Co.	EZL	Class II	1999-09-28
K992810	Hwa (and) Silktex Powder-Free Latex Examination Glove	Hwa Teh Industrial Sdn. Bhd.	LYY	Class I	1999-09-27