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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2709 of 3530

510(k) clearances, page 2709 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882313	Emit D.a.u. Cannabinoid 50 Ng Assay & Calibrators	Syva Co.	LDJ	Class II	1988-08-29
K882226	Series I and II Implants	Saber Technology, Inc.	DZE	Class II	1988-08-29
K882146	Biopro Pc Femoral Hip Component	Biopro, Inc.	JDI	Class II	1988-08-29
K881868	Liquid Chromatography Columns Hisep Column & Guard	Supelco, Inc.	DPM	Class I	1988-08-29
K881850	Teknar Percu-Scan	Teknar, Inc.	IYO	Class II	1988-08-29
K881836	Intermedics Select Shoulder All Plastic Glen. Comp	Intermedics Orthopedics	KWS	Class II	1988-08-29
K881015	Firstday(tm) Early Pregnancy Testing Kit	Pacific Biotech, Inc.	JHI	Class II	1988-08-29
K881013	Multipurpose Digital Gammacamera, Gca-602A	Toshiba Medical Systems	IYX	Class I	1988-08-29
K873562	Vitalograph-Alpha	Vitalograph, Inc.	BZG	Class II	1988-08-29
K883464	Surgical Shirt	Arkansas Lighthouse for the Blind	FYA	Class II	1988-08-26
K883457	Asst-3000 Spinal Surgery Table	Mizuho Orthopedic Systems Inc	FWY	Class I	1988-08-26
K883420	Lancet, Blood	Primrose Medical, Inc.	FMK	Class II	1988-08-26
K883335	Colgate Dental Floss	Colgate-Palmolive Company	JES	Class I	1988-08-26
K883322	Dental Hand Instruments	Collagen Corp.	EKJ	Class I	1988-08-26
K883303	Mentor Rapid-Span (Tm) Tissue Expander	Mentor	FZW	Class I	1988-08-26
K883250	Steri-Clens Wound Care Kit	Absorbent Cotton Co., Inc.	LRO	Class II	1988-08-26
K883024	Oral-B Flossers	Oral-B Laboratories	JES	Class I	1988-08-26
K882772	Lq1106 Ophthalmic Yag Laser	Keeler Instruments, Inc.	GEX	Class II	1988-08-26
K882696	Dermicel, Montgomery Strap	Bioseal	NAD	Class I	1988-08-26
K882491	Cutting Fluid System for Dental High Speed Drills	Steri-Sol, Inc.	EFB	Class I	1988-08-26
K882471	Ite Hearing Aid, Eartech/custom Aid Model Ca	Ear Tech, Inc.	ESD	Class I	1988-08-26
K882392	Burnet Laboratoire Pharmaceutique Surgical Gloves	Roseburg SA	KGO	Class I	1988-08-26
K882021	Pro-Fect Laparotomy Sponges	Network Trading Corp.	EFQ	Unclassified	1988-08-26
K882000	Pro-Fect o.r. Towel	Network Trading Corp.	KKX	Class II	1988-08-26
K881391	Ultrasonic Denture Cleaner	Tatung Company of America, Inc.	JER	Class I	1988-08-26
K883484	Owren's Veronal Buffer	Helena Laboratories, Corp.	JPA	Class II	1988-08-25
K883473	Surgical Connecting Tubes	Westmark, Sterile Packing Systems, Inc. (Sps)	GAZ	Class II	1988-08-25
K883333	Rabbit Plasma Fibrinogen (Rpf) Supplement	IMMY, Inc.	JTL	Class I	1988-08-25
K883208	Histo-Check Slides	Val Tech Diagnostics, Inc.	LJG	Class I	1988-08-25
K883100	Multiple Spectacle Frames	Metal Optics U.S.A., Inc.	HQZ	Class I	1988-08-25
K882503	30 IV Extension Set W/two Male Luer Locks	Vygon Mfg	FPA	Class II	1988-08-25
K882456	Coag-I Pt Test Card	Cardiovascular Diagnostic Services	GJS	Class II	1988-08-25
K882452	Medtronic Models 4057/4557 Endocardial Pacing Lead	Medtronic, Inc.	DTB	Class III	1988-08-25
K882444	Coag-I Analyzer, Alpha Model	Cardiovascular Diagnostic Services	JPA	Class II	1988-08-25
K882370	Sysmex K-1000 18 Parameter, Auto. Hema Analyzer	Toa Medical Electronics USA, Inc.	GKZ	Class II	1988-08-25
K882367	Metatech Microclip Applicator	Metatech Corp.	DWS	Class I	1988-08-25
K882361	Stihler Astotherm Ift 200, Ift 220	Stihler Electronic, C/O Worldwide Regul. Services	LGZ	Class II	1988-08-25
K882325	Unifast Activated Partial Thromboplastin Time Test	Sclavo, Inc.	GFO	Class II	1988-08-25
K882273	Horizon 2000 Pulse Oximetry and Module	Mennen Medical, Inc.	DQA	Class II	1988-08-25
K882238	Vessel Dilator and Introducer Sheath	Ideal Medical, Inc.	DRE	Class II	1988-08-25
K880511	Xact Neisseria	Austin Biological Laboratories	JSX	Class I	1988-08-25
K880314	Hysteroscope Autonom 4992	Richard Wolf Medical Instruments Corp.	HIH	Class II	1988-08-25
K874854	Gps/wgps/preview Gp	Labsonics, Inc.	IYO	Class II	1988-08-25
K873529	Hybriwick System: Herpes DNA Probe Test Kit	Ortho-Clinical Diagnostics, Inc.	GQN	Class II	1988-08-25
K883480	Modified Site Fiber Optic Module for Ophthal. Use	Site Microsurgical Systems, Inc.	FCT	Class II	1988-08-24
K883238	Genesis II Transcranial Probe	Biosound, Inc.	IYO	Class II	1988-08-24
K883226	Optical or Eyeglass Frame	Unique Optic, Ltd.	HQZ	Class I	1988-08-24
K883114	Spetzler Mankind Ventriculostomy External 1114-1	PMT Corp.	JXG	Class II	1988-08-24
K882769	Sunglasses, Non-Prescription	Spotlight Industries, Inc.	HQY	Class I	1988-08-24
K882743	Ohmeda 5250 Rgm (Respiratory Gas Monitor)	GE Healthcare	CCL	Class II	1988-08-24