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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2894 of 3529

510(k) clearances, page 2894 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K861573	Terumo Sensibead Eia Tsh Kit	Terumo Medical Corp.	JLW	Class II	1986-06-19
K861554	Port-a-Trac	Port-A-Trac Co.	JFB	Class II	1986-06-19
K861495	Electrosurgical Blade Electrode (Solid Type)	National Wire & Stamping, Inc.	GEI	Class II	1986-06-19
K861377	Standard/pediatric Cordis Hydrocephalus Valves	Cordis US Corp.	JXG	Class II	1986-06-19
K861372	Electrosurgical Cutting and Coagulation Accessory	Snowden-Pencer	GEI	Class II	1986-06-19
K861079	Staclot Protein C Test Kit	American Bioproducts Co.	GGP	Class II	1986-06-19
K862267	Fome-Cuf and Aire Cuf Tracheostomy Tubes	Bivona Medical Technologies	BTO	Class II	1986-06-18
K862220	Compass CT Stereotactic Adaptation System	Stereotactic Medical Systems, Inc.	HAW	Class II	1986-06-18
K862025	Engstrom Erica II Respirator	Gambro, Inc.	CBK	Class II	1986-06-18
K861468	Impax, Male Impotence Aid	Lehigh Group	LKY	Class II	1986-06-18
K861214	Skylark Gb 1000	Peleg Intl. Co.	GZJ	Class II	1986-06-18
K861117	Anthron Catheters & Sets	Toray Industries (America), Inc.	FOZ	Class II	1986-06-18
K861090	Nutri-Cath - Feeding Tube	Gesco Intl., Inc.	KNT	Class II	1986-06-18
K860826	Venotrain Color Compression Stockings & Pantyhose	Bauerfeind AG	DWL	Class II	1986-06-18
K860271	Biofeedback Microlab	Hrm Software/Div. of Human Relations Media	HCC	Class II	1986-06-18
K855120	Ati Disposable Biological Test Pack	Parke-Davis Co.	FRC	Class II	1986-06-18
K853900	Endo-Lase Cd40 for Neurosurgery	Endo Lase, Inc.	GEX	Class II	1986-06-18
K853898	Skylark Model 1001 TENS Device	Peleg Intl. Co.	GZJ	Class II	1986-06-18
K862223	Micro Thin* Paraffin	Richard-Allan Medical Ind., Inc.	KEO	Class I	1986-06-17
K862207	Quidel Beta Stick Pregnancy Test (Modification)	Ortho-Clinical Diagnostics, Inc.	LCX	Class II	1986-06-17
K862142	Sun-Dreamer Suntanning Bed	Sun-Dream Tanning, Ltd.	FTC	Class II	1986-06-17
K862138	Vision Albumin	Abbott Medical	CJW	Class II	1986-06-17
K862097	Face Tanner	Tan America Mfg.	FTC	Class II	1986-06-17
K862071	Modified Label For/spectrax Sxt Implant. Pulse Gen	Medtronic, Inc.	DXY	Class III	1986-06-17
K862070	Inter-Sharp	Intermedics Intraocular, Inc.	HNW	Class I	1986-06-17
K862041	Wm10, Wm20, Wm30 Power Massager	Associated Mills, Inc.	ISA	Class I	1986-06-17
K862038	Modify Label/spectrax S & Sx Implant Pulse Gener	Medtronic, Inc.	DXY	Class III	1986-06-17
K862037	Modify Label/pasys & Mod 8316/17/18 Implan Pul Gen	Medtronic, Inc.	DXY	Class III	1986-06-17
K862023	Spiromate as-600	Riko Medical & Scientific Instrument Corp.	BZG	Class II	1986-06-17
K862004	Zeiss 30 Sl-L	Carl Zeiss, Inc.	HJO	Class II	1986-06-17
K861990	Soft Lens Folder	Staar Surgical AG	KYB	Class I	1986-06-17
K861927	Children's Sunglasses	Jestroy, Ltd.	HQY	Class I	1986-06-17
K861901	Multi-4 Co-Oximeter Control	Allied Instrumentation Laboratory	JJY	Class I	1986-06-17
K861801	Waxtreat F	Beaute Naturelle International, Inc.			1986-06-17
K861800	Waxtreat B	Beaute Naturelle International, Inc.			1986-06-17
K861798	Vision Total Protein	Abbott Medical	CEK	Class II	1986-06-17
K861592	Wec-Wash, Catalog No. 850-115	Palmetto Chemical & Supply Co., Inc.	FLG	Class I	1986-06-17
K861590	Wec-Kleen, Catalog N. 850-102	Palmetto Chemical & Supply Co., Inc.	FLG	Class I	1986-06-17
K861588	Weck Instrument Cleaner, Cat. No. 850-103	Palmetto Chemical & Supply Co., Inc.	FLG	Class I	1986-06-17
K861584	Gram Negative Combo Panel Type 3	American Micro Scan	JWY	Class II	1986-06-17
K861578	Acuson S328, L382, L538 & L312 Transducers	Acuson Computed Sonography	HGL	Class II	1986-06-17
K861542	Delfia (Tm) Human Prolactin	Lkb Instruments, Inc.	CFT	Class I	1986-06-17
K861482	Resusikit	Begley Enterprises, Inc.	CAE	Class I	1986-06-17
K861400	Threaded Titanium Metal Backed Acetabular Cup	Depuy, Inc.	LZO	Class II	1986-06-17
K861399	Powerstim Electronic Muscle Stimulator	Bio-Med Systems Corp.			1986-06-17
K861047	Model 2100 Nd:yag Surgical Laser Gastrointestinal	Sharplan Industries, Inc.	LNK	Class II	1986-06-17
K861021	Gottex Sunglasses	Private Eyes Sunglass Corp.	HQG	Class I	1986-06-17
K860704	The Keymed Sigmoidoscope Disinfection Stand	Keymed, Inc.	NZA	Class II	1986-06-17
K860681	Disposable Flush Device	Hewlett-Packard Co.	DRS	Class II	1986-06-17
K860464	Vision Theophylline - Addit. of Whole Blood Claim	Abbott Medical	KLS	Class II	1986-06-17