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 2125 of 3531

510(k) clearances, page 2125 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940813	Osteonics(r) Series 7000 Total Knee	Osteonics Corp.	JWH	Class II	1995-01-30
K940582	Massaging Helmet C.f. Hansen Design	Philco Ushuaia	IRO	Class I	1995-01-30
K940046	Non-Lubricated Condom	Ansell, Inc.	HIS	Class II	1995-01-30
K940045	Condom	Ansell, Inc.	HIS	Class II	1995-01-30
K935065	Ogden Anchor Additional Applications	American Medical Electronics, Inc.	JDR	Class II	1995-01-30
K933785	Next Generation Knee System	Zimmer GmbH	JWH	Class II	1995-01-30
K931122	Ovamed Hsg Catheter	Ovamed Corp.	LKF	Class II	1995-01-30
K950206	Fisoneb(r) II	Fisons Corp.	CAF	Class II	1995-01-27
K950063	Wgl Endoscopic Grasper*	Wilson Greatbatch Technologies, Inc.	GCJ	Class II	1995-01-27
K946255	Thermaset	Ormco Corp.	DYH	Class II	1995-01-27
K946241	Endopath(r) Tristar(tm) Dissector and Tissue Manipulator	Ethicon Endo-Surgery Inc	GCJ	Class II	1995-01-27
K946213	Ksea Steiner Electromechanic Morcellatort	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-01-27
K945969	Rapidvue(tm) Hcg	Ortho-Clinical Diagnostics, Inc.	JHI	Class II	1995-01-27
K945894	Mask, Gas, Anesthetic	Hans Rudolph, Inc.	BSJ	Class I	1995-01-27
K945888	Modified Luxar Lx-20 Family C02 Laser System	Luxar Corp.	GEX	Class II	1995-01-27
K945846	Advance(r) Pregnancy Test	Advanced Care Products	LCX	Class II	1995-01-27
K945726	3M(tm) Ear Impression Material	3M Medical Products Group	ESD	Class I	1995-01-27
K945535	Glenroe Ortho-Sil	Glenroe Technologies	EGD	Class I	1995-01-27
K945520	Hemoclip Ecosystem	Pilling Weck, Inc.	GCJ	Class II	1995-01-27
K945394	Innovative Surgical(r) Mangum Knot Pusher	Innovative Surgical, Inc.	GCJ	Class II	1995-01-27
K945234	As/3 Memory Module, M0mem	Datex Division Instrumentarium Corp.	BSZ	Class II	1995-01-27
K945231	Self-Latching Clip	Surgical System, Inc.	FZP	Class II	1995-01-27
K945208	Consensus Hip System -- Trochanteric Cutter	U.S. Medical Products, Inc.	HWE	Class I	1995-01-27
K945189	Consensus Hip System -- Calcar Planer	U.S. Medical Products, Inc.	HWE	Class I	1995-01-27
K945186	Consenus Hip System -- Acetabular Reamer	U.S. Medical Products, Inc.	HWE	Class I	1995-01-27
K944988	Custom Medical Suspension Strap	Custom Medical Specialties, Inc.	JAY	Class I	1995-01-27
K944928	Py30, Py60, Py80	Huttinger Medizintechnik GmbH & CO KG	GEX	Class II	1995-01-27
K944121	Sharps Container 18 Gallon	Bci, Inc.	FMI	Class II	1995-01-27
K943988	Implantech Nasal Labial Implant	Implantech Associates Inc	LZK	Class II	1995-01-27
K943857	External Fixator	Acu Med, Inc.	JEC	Class II	1995-01-27
K943621	Rapid Yeast Plus System	Innovative Diagnostic Systems, Inc.	JXB	Class I	1995-01-27
K943299	Depuy Amk All Polyethylene Posterior Stablilized Tibial Tray	Depuy, Inc.	JWH	Class II	1995-01-27
K943081	Trimline 2000	Pymah Corp.	DXN	Class II	1995-01-27
K943027	Cholesterol Qvet	Prisma Systems	CHH	Class I	1995-01-27
K942582	Sorin Blood Cardioplegia Console	Sorin Biomedical, Inc.	DTQ	Class II	1995-01-27
K942546	Cufflink Non-Invasive Blood Pressure Analyzer	Dynatech/Nevada, Inc.	DXN	Class II	1995-01-27
K942480	M4 Contra-Angle Handpiece	Kerr Corporation (Danbury)	EGS	Class I	1995-01-27
K942394	Safe Vent System	Incutech, Inc.	FMF	Class II	1995-01-27
K942055	Drager-Vapor 19.1	North American Grager	CAD	Class II	1995-01-27
K941997	Bbl Crystal Mrsa Id System	Becton Dickinson Microbiology Systems	JWY	Class II	1995-01-27
K936220	Dideco Vacuum Pump	Dideco S.p.A.	CAC	Class II	1995-01-27
K935781	Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray	Sherwood Medical Co.	FEG	Class II	1995-01-27
K934518	Strato Medical Infuse-a-Port/infuse-a-Kit Periport Peripheral Access System	Strato Medical Corp.	LJT	Class II	1995-01-27
K934383	Prolex (Streptoccal Grouping Latex Kit)	Pro-Lab, Inc.	GTZ	Class I	1995-01-27
K933995	True/flextm Femur Rods, Caps, Screws and Instrumentation	Applied Osteo Systems, Inc.	HSB	Class II	1995-01-27
K933229	Apollo Knee Femoral Component	Intermedics Orthopedics	JWH	Class II	1995-01-27
K946307	Cyrstalline L3 Multi-Use Hybrid Composite	Confi-Dental Products Co.	EBF	Class II	1995-01-26
K946294	Phonak Sono-Forte 332X-Az	Phonak, Inc.	ESD	Class I	1995-01-26
K946264	Unitron Model Soung F/s	Unitron Industries, Inc.	ESD	Class I	1995-01-26
K946263	Brimfield Precision Grasper/dissector	Springfield Surgical Instruments	GCJ	Class II	1995-01-26