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 2864 of 3529

510(k) clearances, page 2864 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863760	2X2 Sponges, Non-Sterile	Medical Group	EFQ	Unclassified	1986-10-24
K863752	Valtrac (Bar) Remover Device	Davis & Geck, Inc.	EMF	Class I	1986-10-24
K863739	Bescure	U-T, Inc.	KNX	Class II	1986-10-24
K863717	Anti-DNA Microassay	Diamedix Corp.	DHN	Class II	1986-10-24
K863680	Imz Intramobile Cylinder Implant System Components	Interpore Intl.	DZE	Class II	1986-10-24
K863617	Ion 2/4 Flow Cell Cleaner (Product #88656)	Hi Chem, Inc.	JGS	Class II	1986-10-24
K863595	Coated Suture Needle	Sharpoint, Inc.	GAB	Class I	1986-10-24
K863568	'Myostim Ex'	Electro Therapeutic Devices Inc	GZJ	Class II	1986-10-24
K863567	'Tensaid'	Electro Therapeutic Devices Inc	GZJ	Class II	1986-10-24
K863491	Blood Specimen Collection Devices	Medelec Intl. Corp.	JKA	Class II	1986-10-24
K863386	Vesico Suprapubic Bladder Drainage & Exchange Sets	Angiomed U.S., Inc.	KOB	Class II	1986-10-24
K863265	Direct Bilirubin Procedure	Data Medical Associates, Inc.	CIG	Class II	1986-10-24
K863225	Unitron Model Ul21 Hearing Aid	Unitron Industries, Inc.	ESD	Class I	1986-10-24
K863183	Nd:yag Laser, Model 6000 for Neurosurgery	Cooper Lasersonics, Inc.	GEX	Class II	1986-10-24
K863168	Model 1101M & 1151M Urolab Micro Urodynamic Record	Life-Tech Intl., Inc.	FAP	Class II	1986-10-24
K863167	Model 1350 Urodynamic Waveform Processor	Life-Tech Intl., Inc.	FAP	Class II	1986-10-24
K863120	(Stamey) T.u.r.p. Suprapubic Catheter Set	Cook Incorporated	KOB	Class II	1986-10-24
K863081	4-Wire (Carson) Stone Extractor	Cook Incorporated	FFL	Class II	1986-10-24
K862969	Ana-Enzyme Immunoassay (Ana-Eia) Diagnostic Kit	Biohytech International, Inc.	LJM	Class II	1986-10-24
K862930	Perfect One	North American Alloys, Inc.	EJH	Class II	1986-10-24
K862872	Flexible Visualization Catheter	American Edwards Laboratories	FEI	Class I	1986-10-24
K862864	Model 20-C W/fl-20A/u for Surgery & Dermatology	Directed Energy, Inc.	GEX	Class II	1986-10-24
K862863	Model 10-C W/lc-10A/u for Ophthalmic & Orbital Use	Directed Energy, Inc.	GEX	Class II	1986-10-24
K862729	Penn 3-Ring Handle	Penn Medical Devices, Inc.	FFL	Class II	1986-10-24
K862408	Model 8-B CO2 Laser for Opthalmic & Orbital Surg	Directed Energy, Inc.	GEX	Class II	1986-10-24
K860953	Sunglasses (Non-Prescription)	Roseburg SA	HQY	Class I	1986-10-24
K863892	Theracare Lounger	American Theracare	IOR	Class I	1986-10-23
K863884	Pulsestar Exercise Bike	Battle Creek Equipment	ISD	Class II	1986-10-23
K863732	Surgical Drape & Drape Accessories	Intera Corp.	KKX	Class II	1986-10-23
K863654	Re-Heater, Hot Pack	K & L Ent.	IME	Class I	1986-10-23
K863590	Universal Cannula System	Aspen Laboratories, Inc.	HRX	Class II	1986-10-23
K863450	Sulky Special	Asc Corp.	LBE	Class I	1986-10-23
K852502	Amendment Ultrasound Scanner Type 1842/1846/1849	Bruel & Kjaer Industri A/S	IYO	Class II	1986-10-23
K863712	i.v. Start Kit, Sterile, Disposables	Busse Hospital Disposables	LRS	Class II	1986-10-22
K863510	Oxy-Off(tm)	B & B Medical Technologies, Inc.	BXY	Class I	1986-10-22
K863504	Obstetrical Kit	Dyna-Med			1986-10-22
K863402	Medi-Plast Disposable Manifold	Medi-Plast Intl., Inc.	DTL	Class II	1986-10-22
K862917	Pathfinder Rotavirus Chemiluminescent	Kallestad Laboratories, Inc.	LIQ	Class I	1986-10-22
K862775	Asserachrom B-Tg Kit	American Bioproducts Co.	JBX	Class II	1986-10-22
K862548	Temperature Sensing Esophageal Transducer	Lawrence Medical Systems, Inc.	BZT	Class II	1986-10-22
K862495	Starcraft Elite Autoclave	Starcraft Medical Corp.	FLE	Class II	1986-10-22
K862435	Double Lumen E T Adaptor	Acutronic Medical Systems AG	BZA	Class I	1986-10-22
K861949	Suction Catheter Kit	Medi-Craft, Ltd.	BSY	Class I	1986-10-22
K863624	Ultrawash II	Dynatech Laboratories, Inc.	JQW	Class I	1986-10-21
K863623	Ultrawash I	Dynatech Laboratories, Inc.	JQW	Class I	1986-10-21
K863502	Solution B- Na 50Meq/l, K 40 Meq/l	Reagent Laboratory, Inc.	JIX	Class II	1986-10-21
K863922	Versaflex(tm) Delta St(tm) Monitor	Versaflex Delivery Systems, Inc.	DSH	Class II	1986-10-20
K863910	Raincoat	Artec Environmental Monitoring Division	BZO	Class I	1986-10-20
K863862	Military Prescription Frame	Halo Optical Products, Inc.	HQZ	Class I	1986-10-20
K863775	Rk Vacuum Fixation Ring System	Ameritek, Inc.	HNH	Class I	1986-10-20