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 2309 of 3531

510(k) clearances, page 2309 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K930721	Rionet Hearing Aid Hb-53S	Authorized Hearing Systems, Inc.	ESD	Class I	1993-04-07
K930567	Modified Endoscopic Clamp	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-04-07
K930542	Hearing Aid (All-in-the-Ear)	Action Labs, Inc.	ESD	Class I	1993-04-07
K930342	Becton Dickinson Arterial Blood Gas Kits	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1993-04-07
K930244	Jpi X-Ray Film Cassette	Jpi, Inc.	IXA	Class II	1993-04-07
K930159	Opticon(tm) Connector Adapter	Xintec Corporation	GEX	Class II	1993-04-07
K930091	Cordis Reflex Steerable Guidewire	Cordis US Corp.	DQX	Class II	1993-04-07
K926498	Endogrip	Biomedix Wai	BTR	Class II	1993-04-07
K926445	Soyee Aluminum Interspaced X-Ray Grid	X-Ray Accessories Mfg. Co.	IXJ	Class I	1993-04-07
K926079	Dmi Laparoscopic Electrodes	Diversified Medical Instruments, Inc.	GCJ	Class II	1993-04-07
K926048	Clarus Endoscopic Ball Probe	Clarus Medical Systems, Inc.	GZX	Class I	1993-04-07
K924632	Lcm-2-Linac Couch-Mount System	Radionics, Inc.	IYE	Class II	1993-04-07
K924630	Surgicad(tm) View(tm)	Surgicad Corp.	LLZ	Class II	1993-04-07
K924627	Xtend Circuits (Tm)	Arc Medical, Inc.	CAI	Class I	1993-04-07
K924537	Lpi Ml210 Holmium Surgical Laser	Laser Photonics, Inc.	GEX	Class II	1993-04-07
K924469	Graspers & Scissors (Minimal Access Surg Instr)	Conmedcorp	GEI	Class II	1993-04-07
K924382	Bard(r) Intra Aortic Balloon	C.R. Bard Inc	DSP	Class II	1993-04-07
K924366	Personal Display System	Vortech Data, Inc.	LLZ	Class II	1993-04-07
K924283	Microsurge Detacha-Tip Surgical Instruments	Microsurge, Inc.	GEI	Class II	1993-04-07
K924035	Endopath II Disposable Surgical Trocar & Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1993-04-07
K923829	Lifecare 175 Infuser -- Modification	Abbott Medical	FRN	Class II	1993-04-07
K923818	O.r. Concepts' Irrigating Kittner	O.R. Concepts, Inc.	FGS	Class II	1993-04-07
K923648	Lectro-Larynx	Bruce Medical Supply	ESE	Class I	1993-04-07
K923368	Magic Infusion Catheter	Target Therapeutics	KRA	Class II	1993-04-07
K923359	Port-Xp	Mobile Dental Equipment Corp.	IZL	Class II	1993-04-07
K922935	Conbio-Medlite Q-Switched Nd:yag Laser System	Buckman Co., Inc.	GEX	Class II	1993-04-07
K922577	Conbio-Medlite(tm) Q-Switched Nd:yag Laser System	Continuum Biomedical, Inc.	GEX	Class II	1993-04-07
K922162	Curity Plastic Loss of Resistance Syringe	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1993-04-07
K921740	Computer Assisted Stereotactic Surgery -- Modified	Medical Instrumentation & Diagnostics Corp.(Midco)	IYE	Class II	1993-04-07
K920965	Straight-Lines i.v. Organizer	Taylor Bio-Medical, Inc.	FRA	Class II	1993-04-07
K930488	Besure Plus/(midstream) One Step Preg Home Test	Syntron Bioresearch, Inc.	LCX	Class II	1993-04-06
K930417	Synelisa Scl-70 Antibodies	Elias U.S.A., Inc.	LLL	Class II	1993-04-06
K930281	Synelisa Jo-1 Antibodies	Elias U.S.A., Inc.	LLL	Class II	1993-04-06
K926579	Techmedica 6.5Mm Self-Tapping Cancellous Bone Scre	Techmedica, Inc.	HWC	Class II	1993-04-06
K926569	Immuno Ra Undiluted	Immunostics, Inc.	DHR	Class II	1993-04-06
K925875	Horizontal Needle Guide Attachment	Bip USA, Inc.	GDF	Class I	1993-04-06
K924981	Operative Cholangiogram Catheter	Taut, Inc.	GBZ	Class I	1993-04-06
K924938	Theo Non-Prescription Sunglasses/spectacle Frames	Eyeworks 3	HQY	Class I	1993-04-06
K924741	Optec 3000	Stereo Optical Company LLC	HKO	Class I	1993-04-06
K924610	Baxter Adult/pedi/infant Single Use Man Resuscit	Engineered Medical Systems, LLC	BTM	Class II	1993-04-06
K924571	Medi-Sol	Orange-Sol, Inc.	KOX	Class I	1993-04-06
K924548	Xeno Melanin Lens	Photoprotective Technologies	HQY	Class I	1993-04-06
K924304	Bite Block	United States Endoscopy Group, Inc.	JXL	Class II	1993-04-06
K924007	Quikpac Strep a Test	Syntron Bioresearch, Inc.	GTZ	Class I	1993-04-06
K923983	Peg Guidewire System Gastrostomy Tube Kit	Sandoz Nutrition	KNT	Class II	1993-04-06
K923726	Kensey Nash Dynamic Clip System	DSM Biomedical, Inc.	GCJ	Class II	1993-04-06
K922847	Perfecta Total Hip System	Orthomet, Inc.	JDI	Class II	1993-04-06
K922326	Lupo-Test Regeant	Graoipore, Ltd.	GIR	Class I	1993-04-06
K922156	Lucor Confirmatory Reagent	Gradipore, Ltd.	GIR	Class I	1993-04-06
K914791	Gish Arterial Filter	Gish Biomedical, Inc.	DTM	Class II	1993-04-06