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 2914 of 3529

510(k) clearances, page 2914 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860298	Stableline	Cardio Metrics, Inc.	KRI	Class I	1986-04-02
K860246	Endoscope Accessories, Cleaning, for Endoscope	Buckman Co., Inc.	PUP	Class II	1986-04-02
K853216	Master Endomet Biopsy Kit W/plas Cure 3,4Mm-4003,4	Gyneco, Inc.	HHK	Class II	1986-04-02
K861170	Narkomed 3 Anesthesia System (Modified)	Draeger, Inc.	BSZ	Class II	1986-04-01
K861166	Oxygen Therapy Regulator or Regulator-Flowmeter	Victor	CAN	Class I	1986-04-01
K860913	Siregraph D	Siemens Medical Solutions USA, Inc.	IXR	Class II	1986-04-01
K860761	Multi-Image Camera, Series 2100, Model #2100-06	Lenzar Optics Corp.	LMC	Class II	1986-04-01
K860558	Esophageal Stethoscope	Sharn, Inc.	BZW	Class I	1986-04-01
K860535	Unilateral Oxygen Delivery System (Ulods)	Andover Medical, Inc.	CAT	Class I	1986-04-01
K860455	Model 9000 Recording System/respiration Monitoring	Oxford Medilog, Inc.	BZQ	Class II	1986-04-01
K860002	Conical Collar Hip Prosthesis Porous Coated	Kirschner Medical Corp.	JDI	Class II	1986-04-01
K855200	Modular Press Fit (Mpf) Stem	Depuy, Inc.	JDI	Class II	1986-04-01
K855150	Hpk-a Device Dfor the Treatment of Hemorrhoids	Hpk International, Inc.	LKX	Unclassified	1986-04-01
K861013	Electrically Controlled i.v. Pole (Opthalmic)	Ameritek, Inc.	KYG	Class I	1986-03-31
K860986	Model 366-09 Adaptaid Adapter Sleeve	Intermedics, Inc.	DTB	Class III	1986-03-31
K860985	Model 366-19 Adaptaid Adapter Sleeve	Intermedics, Inc.	DTB	Class III	1986-03-31
K860960	Rare Earth Intra-Ocular Magnet	Ameritek, Inc.	HPN	Class I	1986-03-31
K860955	Spectacles Lens	Roseburg SA	HQG	Class I	1986-03-31
K860954	Spectacles Frame	Roseburg SA	HQZ	Class I	1986-03-31
K860832	Model 366-08 Adaptaid Connector Adapter	Intermedics, Inc.	DTD	Class II	1986-03-31
K860806	Regulated Pressure Injector	Target Therapeutics	DXF	Class II	1986-03-31
K860744	Opthalmic Surgical Instruments	Tridak Division of Indicon, Inc.	HMX	Class I	1986-03-31
K860580	Acs Brachial Coronary Guiding Cath W/tapered Tip	Advanced Cardiovascular Systems, Inc.	DQO	Class II	1986-03-31
K860570	Angio-Flo Continuous Arterial Cath Flush Device	Parke-Davis Co.	KRA	Class II	1986-03-31
K860533	(.O38) Hi-Torque Guide Wires	Target Therapeutics	DQX	Class II	1986-03-31
K860432	Percutaneous Introducer Kit	Cormed, Inc., Sub. C.R.Bard, Inc.	DYB	Class II	1986-03-31
K860339	Percutaneous Catheters	Micor, Inc.	DQY	Class II	1986-03-31
K860291	Tubing Connectors	Biomedical Exports, Inc.	DTL	Class II	1986-03-31
K860283	Ami Cardio-Pad	Andover Medical, Inc.	DRO	Class II	1986-03-31
K860167	Prodigy and Prodigy Plus	Cardiodata Corp.	DSI	Class II	1986-03-31
K860149	Venous Perfusion Cannula W/cuff Cat. No. 94015	Dlp, Inc.	DWF	Class II	1986-03-31
K860024	Fukuda Denshi Cardimax Fcp-211	Brentwood Instruments, Inc.	DSI	Class II	1986-03-31
K855105	Simmons Shell	Mira, Inc.	HQT	Class II	1986-03-31
K855082	Defib-Pads	Conmedcorp	LDD	Class II	1986-03-31
K855015	Noninvasive Temp. Pacemaker Ntp-1000	Zmi Corp.	DRO	Class II	1986-03-31
K854984	Cup Monitoring Kit Cvpk-14	Medical Components, Inc.	DQY	Class II	1986-03-31
K854831	Valvokit	Novamed Products, Inc.	DYB	Class II	1986-03-31
K854830	Acs Hi-Torque Tapered Diameter Guide Wires	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1986-03-31
K854319	Schneider-Shiley Peripheral Dilatation Catheter	Shiley, Inc.	LIT	Class II	1986-03-31
K853669	Model 43400A Real-Time Ambulatory ECG Monitor Anal	Hewlett-Packard Co.	DSI	Class II	1986-03-31
K852973	Unilith 2 Pulse Generators #7550, 7552, 7760, 7762	Ela Medical, Inc.	DXY	Class III	1986-03-31
K861075	American Orthopaedic Cast Cutter, Model 0295-202	Martin Medical	LGF	Class I	1986-03-28
K861074	American Orthopaedic Cast Cutter, Model 0295-200	Martin Medical	LGF	Class I	1986-03-28
K861073	American Orthopaedic Vacuum 0295-250	Martin Medical	LGF	Class I	1986-03-28
K861043	Spinal Excursion Meter	Devcom, Inc.			1986-03-28
K860932	Ultrasun 1000 & 2000 Suntanning Unit	Medical Device Consultants, Inc.	FTC	Class II	1986-03-28
K860931	Ultrasun 3000 and 5000 Suntanning Unit	Medical Device Consultants, Inc.	FTC	Class II	1986-03-28
K860930	Ultrasun 2500 Suntanning Unit	Medical Device Consultants, Inc.	FTC	Class II	1986-03-28
K860929	Ultrasun 4000 Ft & 15000-8 Suntanning Unit	Medical Device Consultants, Inc.	FTC	Class II	1986-03-28
K860925	Dermaspandere	Mri Ventures, Inc.	GFD	Class I	1986-03-28