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 2133 of 3531

510(k) clearances, page 2133 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945365	Horizon 55 Bi-Con	Westcon Contact Lens Co., Inc.	LPL	Class II	1994-12-28
K945344	Cedia Dau Barbiturate Assay	Microgenics Corporation	DIS	Class II	1994-12-28
K945335	Cherry Dissector	Lorrex Health Products	GDY	Class I	1994-12-28
K945333	Kittner Dissector	Lorrex Health Products	GDY	Class I	1994-12-28
K944932	Phenobarbital Flex Reagent Cartridge	Dupont Medical Products	DLZ	Class II	1994-12-28
K944752	Orthomet Resurfacing Femoral Component	Orthomet, Inc.	KXA	Class II	1994-12-28
K944277	Dynamo	Pride Health Care, Inc.	INI	Class II	1994-12-28
K944085	Ace(tm) Cedia(r) Phenytoin Assay	Schiapparelli Biosystems, Inc.	DIP	Class II	1994-12-28
K943698	Stat Padz Sterile Adult Multi-Function Electrodes	ZOLL Medical Corporation	MKJ	Class III	1994-12-28
K943437	Aqualite Fsh	Sealite Sciences, Inc.	CGJ	Class I	1994-12-28
K940301	Compex 2	Sport Medical Technology Inc	IPF	Class II	1994-12-28
K940233	Neoscreen Elisa Hydroxyprogesterone	Pantex	JLX	Class I	1994-12-28
K946044	Disposable Gas Sampling Lines	Biomerics	CCK	Class II	1994-12-27
K945984	Meridian Medical Systems Mapleson D and Modified Jackson Reese Circuits	Meridian Medical Systems, LLC	CAI	Class I	1994-12-27
K945950	Triguard(tm) Suction System	Vital Signs, Inc.	BSY	Class I	1994-12-27
K945901	Direct View 2001 Fiberlight	Mercury Medical	CCW	Class I	1994-12-27
K945874	Euromedical Poly Tracheotomy Tube	Regulatory & Marketing Services, Inc.	JOH	Class II	1994-12-27
K945668	Kxo-80G	Toshiba America Medical Systems, In.C	IZO	Class I	1994-12-27
K945496	Mammographic X-Ray Unit	Lorad Corp.	IZH	Class II	1994-12-27
K945242	Nerve Monitor Electrodes/stimulator Probes	Micromed Development Corp.	ETN	Class II	1994-12-27
K944881	Skin Scrub Tray	Clinical Resources, Inc.	FRG	Class II	1994-12-27
K944764	Vti Disposable Pressure Display Set	Vascular Technology Incorporated	DXS	Class II	1994-12-27
K944758	Sunrise Technologies Model 5020 Pldd Kit	Cardiogenes	GEX	Class II	1994-12-27
K944645	Siemens Frontier Serice, Models S-1,S-2 and S-3 Multiple Situation, Single Channel Programmable Instruments	Siemens Hearing Instruments, Inc.	ESD	Class I	1994-12-27
K944563	Family of Primus Forceps: Graspers/dissectors/suturers/needle Drivers	Marlow Surgical Technologies, Inc.	HET	Class II	1994-12-27
K944520	Air Conduction Hearing Aid	Unitron Industries, Inc.	ESD	Class I	1994-12-27
K944518	Widex Model Logo 8S	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-12-27
K944411	P/2000	Plexus Medical	FNM	Class II	1994-12-27
K944407	Olympus Magnesium Reagent	OLYMPUS Corporation of the Americas	JGJ	Class I	1994-12-27
K944404	Mo4 Series	Philips Hearing Instruments Co.	ESD	Class I	1994-12-27
K944240	Soft Sock	Silipos, Inc.	FQL	Class I	1994-12-27
K944174	Lifesound Multiple Situation, Single Channel Programmable Instruments	Siemens Hearing Instruments, Inc.	ESD	Class I	1994-12-27
K944041	Personal Hearing System	Resound Corp.	LRS	Class II	1994-12-27
K943287	Act-One Advanced Compression Technology Foot Pump	Ndm Acquisition Corp.	JOW	Class II	1994-12-27
K943272	Visualizer 2000	Vf-Works, Inc.	JAA	Class II	1994-12-27
K942601	Psi Flexible Arm	V. Mueller Neuro/Spine	GCJ	Class II	1994-12-27
K942379	Daig Diagnostic Electrophysiology Catheter	Daig Corp.	DRF	Class II	1994-12-27
K933981	Cervical Catheter	Conceptus, Inc.	LKF	Class II	1994-12-27
K933723	Conceptus Uterine Catheter	Conceptus, Inc.	LKF	Class II	1994-12-27
K925582	Medison 4800	Medison America, Inc.	IYO	Class II	1994-12-27
K923273	Ai 5200 Diagnostic Ultrasound System	Acoustic Imaging Technologies Corp.	IYO	Class II	1994-12-27
K911431	Tactylon(tm) Condom	Tactyl Technologies, Inc.	HIS	Class II	1994-12-27
K945710	In-the-Ear Hearing Aid	Truetone Hearing Systems, Inc.	ESD	Class I	1994-12-23
K945703	Widex Model Logo - L9	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-12-23
K945527	Karl Storz Telescope Bridges and Adapters	Karl Storz Endoscopy-America, Inc.	FAJ	Class II	1994-12-23
K945481	Shave Prep Kit	Harding Industries, Inc.	LRO	Class II	1994-12-23
K945455	General Anesthesia System	Vital Signs, Inc.	BTR	Class II	1994-12-23
K945421	Chakoff Endoscopy	Stephen Chakoff, Inc.	FDG	Class I	1994-12-23
K945021	Fluff Gauze Sponge	Clinical Resources, Inc.	EFQ	Unclassified	1994-12-23
K945020	Fluff Gauze Sponge	Clinical Resources, Inc.	EFQ	Unclassified	1994-12-23