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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3187 of 3528

510(k) clearances, page 3187 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K823267	Factor VIII Related Antigen Rocket Eid	Helena Laboratories, Corp.	GGP	Class II	1982-12-28
K823241	New Freedom Thin Unscented Maxi Pads	Kimberly-Clark Corporation	HHD	Class I	1982-12-28
K823222	Intraocular Lens Guide	American Medical Optics	KYB	Class I	1982-12-28
K823123	Cordia Cmv	Cordis US Corp.	LFZ	Class II	1982-12-28
K823016	Candida Detection System	Ramco Laboratories, Inc.	LHK	Class II	1982-12-28
K822923	5012 Parabolic Stimulator	Life-Tech Intl., Inc.	HLX	Class II	1982-12-28
K822922	5011 Ganzfeld Stimulator	Life-Tech Intl., Inc.	HLX	Class II	1982-12-28
K822919	5010 Visustim	Life-Tech Intl., Inc.	HLX	Class II	1982-12-28
K822915	5031 Bright Flash Stimulator	Life-Tech Intl., Inc.	HLX	Class II	1982-12-28
K822902	Mini-Vac Drain System	Angus Medical Co.	GCY	Class I	1982-12-28
K822866	Moxalactam	Lilly Research Laboratories	JTT	Class II	1982-12-28
K822804	Operating Room Procedural Pack	Adicon			1982-12-28
K822219	Human Plasma Control for Cea-Roche	Hoffmann-La Roche, Inc.	JJX	Class I	1982-12-28
K828620	Multi Image Camera	Lenzar Medical Corp.			1982-12-27
K822542	Polycore	Polycore Optical Pte, Ltd.			1982-12-27
K822541	Visiopal 75	Polycore Optical Pte, Ltd.			1982-12-27
K822431	Sunglass & Safety Plano Lens	Polycore Optical Pte, Ltd.			1982-12-27
K822430	Kryptox-Round Segment Bifocal	Polycore Optical Pte, Ltd.			1982-12-27
K822429	Single Vision Power Lens	Polycore Optical Pte, Ltd.			1982-12-27
K823402	Ultrachem Bun-UV-Gem Saec Appli.#65080&	EMD Millipore Corporation	CDQ	Class II	1982-12-26
K823858	Volume Ventilator	Medtronic, Inc.	CBK	Class II	1982-12-22
K823678	Telemetry Decoder #540-02	Intermedics, Inc.	DXY	Class III	1982-12-22
K823620	Plastic Elastomer in Cube Form Exercise	Fred Sammons, Inc.	ION	Class I	1982-12-22
K823619	Plastic Elastomer Encased in Terry Cloth	Fred Sammons, Inc.	ION	Class I	1982-12-22
K823618	Progressive Resistance Exercise Cuff	Fred Sammons, Inc.	ION	Class I	1982-12-22
K823617	Plastic Slip-on Points W/rubber Tip for	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823616	Plastic Slip-on Pen/pencil Holder	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823615	Telephone Adaptor-Persons Cant Answer	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823614	Flexible Holder to Hold Phone Receiver	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823613	Plastic Stop to Hold Telephone Button	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823610	Bk-4015 Economy Communication Sheet	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823609	Kit of Words & Ltrs to Re-Learn-Bk4014	Fred Sammons, Inc.	ILP	Class I	1982-12-22
K823602	Regular Shoe Horn W/cylindrical Handle	Fred Sammons, Inc.	ILD	Class I	1982-12-22
K823601	Wrist Support	Fred Sammons, Inc.	ILH	Class I	1982-12-22
K823600	Solid Wood Cone	Fred Sammons, Inc.	IOD	Class I	1982-12-22
K823596	Clamp on Holder for a Glass or Cup	Fred Sammons, Inc.	KNO	Class I	1982-12-22
K823595	Head Support for Wheelchair	Fred Sammons, Inc.	KNO	Class I	1982-12-22
K823594	Plastic Built-Up Handle Eating Utensils	Fred Sammons, Inc.	ILC	Class I	1982-12-22
K823589	H 12 07	Hospal Medical Corp.	KDI	Class II	1982-12-22
K823528	Glislens	Bio-Products, Inc.	HPX	Unclassified	1982-12-22
K823484	Thermal Dilution Catheter	Instrumentation Laboratory Co.	DYG	Class II	1982-12-22
K823481	Be #16 - Manifold	Instrumentation Industries, Incorporated	BZO	Class I	1982-12-22
K823459	Philly Bolt Adult Procedure Kit	Philadelphia Medical Specialties	GWN	Class II	1982-12-22
K823406	Guardian 110, Vol. Control Deliv. Sys	Avi, Inc.	FRN	Class II	1982-12-22
K823404	Volumeric Controller	Quest Medical, Inc	LDR	Class II	1982-12-22
K823387	Sopheia Gentamicin Eia Kit	Siemens Healthcare Diagnostics Inc.	LCD	Class II	1982-12-22
K823380	125-I Lh Radioimmunoassay Kit	Clinetics Corp.	CEP	Class I	1982-12-22
K823379	125-I Fsh Radioimmunoassay Kit	Clinetics Corp.	CGJ	Class I	1982-12-22
K823371	Durapulse	Cpm International, Inc.	DXY	Class III	1982-12-22
K823354	Ultrachem Enzymatic Cholesterol Oxidase	EMD Millipore Corporation	CHH	Class I	1982-12-22