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 2267 of 3531

510(k) clearances, page 2267 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931479	Softouch Diagnostic Intravascular Catheter	Mallinckrodt Medical	DQO	Class II	1993-10-06
K931389	Item # 754 Hot Flip Shades	Ja-Ru, Inc.	HQY	Class I	1993-10-06
K931106	Biosurge(tm) Synchronous Autotrans Procedure Kit	Deknatel, Inc.	CAC	Class II	1993-10-06
K925106	Implantable Pulse Generators	Medtronic, Inc.	DYX	Class II	1993-10-06
K934134	Distention Instrument, Modification	Origin Medsystems, Inc.	GCJ	Class II	1993-10-05
K933431	Orthotrac Coaxial Laser	Trac Medical, Inc.	OXO	Class II	1993-10-05
K933306	Imc 5.0Mm Irrigation/aspiration Probe W/holes	Inman Medical Corp.	GCY	Class I	1993-10-05
K933305	Imc 5.0Mm Irrigation/aspiration Probe	Inman Medical Corp.	GCY	Class I	1993-10-05
K933103	Digital Image Communications System	Analogic Corp.	LMD	Class I	1993-10-05
K932930	Candela Minibrush	Candela Corporation	FEB	Class II	1993-10-05
K932492	Implantology Module, Model 2175	Micro Surgical Instruments Corp.	JEY	Class II	1993-10-05
K932305	Vila-Cooke(tm) Anesthesia Pillow	Sharn, Inc.	CCX	Class I	1993-10-05
K931982	New England Medical Grounding Pad	New England Medical Corp.	GEI	Class II	1993-10-05
K931959	Jarit Surgical Instruments	J. Jamner Surgical Instruments, Inc.	GEI	Class II	1993-10-05
K931070	Closed End Fiberoptic Laser Delivery System	Lca, Inc.	GEX	Class II	1993-10-05
K926501	Branemark System(r) - 5.5Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-05
K926440	Powder-Free Examination Glove	Slim River Latex Sdn. Bhd.	LYY	Class I	1993-10-05
K925765	Branemark System Standard 3.75Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-05
K925764	Branemark System 4.00 Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-05
K925761	Branemark System 5.0 X 14Mm Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-05
K925760	Branemark System Conical Self-Tapping Fixture	Nobelpharma USA, Inc.	DZE	Class II	1993-10-05
K924820	Hypogrip(tm)	Collett Products	FMI	Class II	1993-10-05
K923354	Port Opii, Port Opiii	Mobile Dental Equipment Corp.	EIA	Class I	1993-10-05
K920792	Softcup(tm):2	Ultrafem, Inc.	HHE	Class II	1993-10-05
K934198	Optikos Shami, Inc. Spectacle Frames	Optikos Shami, Inc.	HQZ	Class I	1993-10-04
K934033	Spectacle Frames	H.M.O. Optical, Inc.	HQZ	Class I	1993-10-04
K933252	Il Test (Tm) Pt-Fibrinogen Hs Plus	Instrumentation Laboratory Co.	GJS	Class II	1993-10-04
K931044	Oxy-Bloc	Gi Supply	MNK	Class I	1993-10-04
K930712	P.f.c. Total Hip System Porous Coated Modular	Johnson & Johnson Orthopaedics, Inc.	LZO	Class II	1993-10-04
K930026	Poly-Med Disposable Personal Protection Kit	Medtek Development Corp.	FYC	Class II	1993-10-04
K924250	Plastic Low Profile Subcutaneous Port	Bard Access Systems, Inc.	LJT	Class II	1993-10-04
K923032	Fixel External Fixation Device	Amp, Inc.	KTT	Class II	1993-10-04
K921910	Sterrad Chemical Indicator	Johnson & Johnson MEDICAL GmbH	JOJ	Class II	1993-10-04
K934235	Sniff Position Pillow	American Medical Development, Inc.	CCX	Class I	1993-10-01
K933733	Marchon/marcolin Eyeglasses	Marchon Eyewear, Inc.	HQZ	Class I	1993-10-01
K933684	Il Test Carbamazephine	Instrumentation Laboratory Co.	KLT	Class II	1993-10-01
K933571	Radias Folate Enzyme Immunoassay	Bio-Rad	CGN	Class II	1993-10-01
K933466	Usci Mach 10 Guide Wire with Pro/pel Coating	C.R. Bard Inc	DQX	Class II	1993-10-01
K933429	Multiple	Sam Chung Optical Co., Ltd.	HQZ	Class I	1993-10-01
K933412	Saline Solution-Sterile	Trinity Laboratories, Inc.	JOH	Class II	1993-10-01
K933309	Prince	Goldsmith & Revere, Inc.	EJJ	Class II	1993-10-01
K933160	Procedure Kits	Ethicon Endo-Surgery Inc	GCJ	Class II	1993-10-01
K933138	Influence,aria,maserati,rochas,angelo,tarlazzi	Aria Advanced Eyewear, Inc.	HQY	Class I	1993-10-01
K932992	Spectacle Frames	Vivid Optical Co., Ltd.	HQZ	Class I	1993-10-01
K932764	Therapeutic Stimulator 300(Ts-300) & 300P(ts-300P)	Myo/Kinetic Systems, Inc.	IPF	Class II	1993-10-01
K932716	Emit(r) Thc 50/100 Ng Assay	Syva Co.	LDJ	Class II	1993-10-01
K932275	Sunglasses	Kam Cheong Plastic Factory, Ltd.	HQY	Class I	1993-10-01
K932263	Solosite Dermal Wound Gel	Smith & Nephew United, Inc.	MGQ	Unclassified	1993-10-01
K932125	Optical Accessories-Spectacle Frames and Sunglasses	Vision Design Eyewear, Inc.	HQZ	Class I	1993-10-01
K931972	Frame - Spectacle	Eyetel Optics, Inc.	HQZ	Class I	1993-10-01