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 2222 of 3531

510(k) clearances, page 2222 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940336	Certi Heat Instant Heat Compress	Certified Safety Mfg Inc	IMD	Class I	1994-03-07
K940333	Eye Pad	Certified Safety Mfg Inc	HMP	Class I	1994-03-07
K940260	Thermal Pulp Tester	Union Broach, Div. Moyco Industries, Inc.	EAT	Class II	1994-03-07
K940238	Tumble Forms Junior Tristander	Camp Intl., Inc.	INW	Class I	1994-03-07
K940210	Visitec Eye Pad	Visitec Co.	EFQ	Unclassified	1994-03-07
K940165	Alastik	Unitek Corp.	ECI	Class I	1994-03-07
K936226	Surgimed Breast Localization Needle Wire Set	Meadox Medicals, Div. Boston Scientific Corp.	KDC	Class I	1994-03-07
K936189	Playtex Ultimates Tampons/unscented and Scented	Playtex Family Products, Inc.	HIL	Class II	1994-03-07
K936052	Brady Medical Products Hysorb(tm) Wound Dressing	Brady Medical Products Co.	KMF	Class I	1994-03-07
K935874	Cook Coagulator Probe	Cook Incorporated	GEI	Class II	1994-03-07
K935852	Comfit Powder Free Examination Gloves (Hypoallergenic)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-03-07
K935834	Tas-211/2.3 Ultrathin Flexible Endoscope	Technology Marketing Group	FBN	Class II	1994-03-07
K935735	Attachment Bond	Kulzer GmbH	KLE	Class II	1994-03-07
K935694	Sienet Diagnostic Reporting Console Va02 Upgrade	Siemens Medical Solutions USA, Inc.	LLZ	Class II	1994-03-07
K935660	Medicotex(trademark Application Pending)	Itochu International, Inc.	FYA	Class II	1994-03-07
K935645	Flowgun Reusable Irrigation Probes	O.R. Concepts, Inc.	GCJ	Class II	1994-03-07
K935572	Solarc 1000 Series Ultraviolet Phototherapy Lamp Unit	Solarc Systems Inc.	FTC	Class II	1994-03-07
K935569	Instant Hot or Cold Disposable Pack	CRYOPAK INDUSTRIES Inc.	IMD	Class I	1994-03-07
K935557	Urinary Drainage Bag	Puritas Health Care, Inc.	KNX	Class II	1994-03-07
K935503	Davol Laparoscopic Insufflation Tubing Set	Davol, Inc.	HIF	Class II	1994-03-07
K935439	Snj Smoke Evacuation Suction Wand	Lca, Inc.	FYD	Class II	1994-03-07
K935389	Conmed Veni-Gard i.v. Dressing	Conmedcorp	KMK	Class I	1994-03-07
K935276	Playtex Non-Deodorant Tampons, Playtex Deodorant Tampons	Playtex Family Products, Inc.	HIL	Class II	1994-03-07
K935227	Maxxus Orthopaedic Latex Surgical Gloves	Johnson & Johnson MEDICAL GmbH	KGO	Class I	1994-03-07
K935058	Factor	Sigma Diagnostics, Inc.	GJT	Class II	1994-03-07
K935056	Factor VII Deficient Plasma	Sigma Diagnostics, Inc.	GJT	Class II	1994-03-07
K935054	Factor X Deficient Plasma	Sigma Diagnostics, Inc.	GJT	Class II	1994-03-07
K935012	Biometric Total Hip System	Osteo-Technology Intl., Inc.	JDI	Class II	1994-03-07
K934964	Electromedics Tympanic Temperature Sensor	Electromedics, Inc.	FLL	Class II	1994-03-07
K934940	Miracle-Ear Entre	Miracle-Ear, Inc.	ESD	Class I	1994-03-07
K934883	3D Video System	Richard Wolf Medical Instruments Corp.	FWG	Class I	1994-03-07
K934828	Conmed Universal Plus	Conmedcorp	GEI	Class II	1994-03-07
K934721	Extra Care	Genting Sempurna Sdn. Bhd.	LYY	Class I	1994-03-07
K934524	Mast Cla Allergy System	Mast Immunosystems	DHB	Class II	1994-03-07
K934370	Bip Biopsy Needle Modification	Bip USA, Inc.	FCG	Class II	1994-03-07
K934137	Opus(r) Serology Controls, Modification	Pb Diagnostic Systems, Inc.	MJX	Class I	1994-03-07
K934131	Deroyal Surgical Disposable Insufflation Tubing	DeRoyal Industries, Inc.	HIF	Class II	1994-03-07
K934083	Playtex Ultimates Tampons	Playtex Family Products, Inc.	HIL	Class II	1994-03-07
K933907	Storz Fiberoptic Pick Manipulator	Storz Instrument Co.	HQE	Class II	1994-03-07
K933839	Master Screen Pnuemo	Erich Jaeger, Inc.	BTY	Class II	1994-03-07
K933618	Eagle Medical Anti-Fog Kit	Eagle Medical Intl.	OCT	Class II	1994-03-07
K933570	Resolution(tm) Hip Stem	Wrightmedicaltechnologyinc	LJW	Class I	1994-03-07
K933521	Speculum	Bioteque America Inc	HIB	Class II	1994-03-07
K933462	Conical Abutment	ZimVie US Corp LLC	DZE	Class II	1994-03-07
K933359	Osteonics 22Mm, +10 Neck Bearing Heads	Osteonics Corp.	LWJ	Class II	1994-03-07
K933265	Acu-Dispo-Ce(tm)	Acuderm, Inc.	MDM	Class I	1994-03-07
K933193	Impla-Med Ucla Type Abutments,screwdriver,reamer,l	The Stern Metals Co., Inc.	DZE	Class II	1994-03-07
K933135	Dawn Disposable Biopsy Forceps	Dawn Medical	FCL	Class I	1994-03-07
K933004	Pegasus Biwave System	Pegasus Airwave, Inc.	FNM	Class II	1994-03-07
K932909	Playtex Ultimates Tampons	Playtex Family Products, Inc.	HIL	Class II	1994-03-07