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 2189 of 3531

510(k) clearances, page 2189 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K921732	Minor Lap Set	Medikmark, Inc.	KOH	Class I	1994-06-15
K921730	C-Section Pack	Medikmark, Inc.	KOH	Class I	1994-06-15
K942482	Pressure Monitoring Extension	Surgical Technologies, Inc.	DQO	Class II	1994-06-14
K941877	Ll-55 (Methafilcon a) for Daily Wear	Lombart Lenses, Ltd.	LPL	Class II	1994-06-14
K941334	Davol Laparoscopic Suction Irrigation Probe	Davol, Inc.	HET	Class II	1994-06-14
K941311	First Aid/truma Kit	Certified Safety Mfg Inc	LRR	Not classified	1994-06-14
K940995	Reliant Constriction Ring	Walling Medical Equipment Co.	LKY	Class II	1994-06-14
K936132	Exeter All Plastic Acetabular Component	Howmedica Corp.	JDI	Class II	1994-06-14
K935364	Miniox 1000 Oxygen Concentration Indicator	Minesafety Appliances Co.	CCL	Class II	1994-06-14
K934938	Temporary Screening Lead/catheter Kit	Medtronic, Inc.	GZB	Class II	1994-06-14
K931617	Exactech Ziramic Femoral Head Component	Exactech, Inc.	LZO	Class II	1994-06-14
K930535	If400	Skylark Device Co., Ltd.	LIH	Class II	1994-06-14
K922420	Continuous Flow Hystero-Resectoscope	Linvatec Corporation	HIH	Class II	1994-06-14
K922323	Mx4042/mc4044 Series Simulcath(tm)	Medex, Inc.	KXO	Class II	1994-06-14
K942415	R-Bar Retractor	Linvatec Corporation	GCJ	Class II	1994-06-13
K942304	Microflex	Moeller Microsurgical, Inc.	FSO	Class I	1994-06-13
K942156	Epi-Derm Silicone Gel Sheeting	Biodermis LLC	MDA	Class I	1994-06-13
K941976	Wheelchair,mechanical	Tone World International	IOR	Class I	1994-06-13
K941712	Cobas-Fp Reagents and Calibrators	Roche Diagnostic Systems, Inc.	LGJ	Class II	1994-06-13
K941642	Ascenda	American Stair-Glide Corp.	ING	Class II	1994-06-13
K941379	Ace Sports Tape	Becton Dickinson Consumer Products	KGX	Class I	1994-06-13
K941255	Cedia Digoxin Plus Assay	Microgenics Corporation	KXT	Class II	1994-06-13
K941254	Dye Management System	Abbott Medical	DQO	Class II	1994-06-13
K941142	Kodak Ektachem Clinical Chemistry Slide Phenytoin	Eastman Kodak Company	DIP	Class II	1994-06-13
K941011	Acu-Sizer(tm)	Applied Medical Resources Corp	EYB	Class II	1994-06-13
K940616	Skytron Elite 3500 Table	Skytron, LLC	GDC	Class I	1994-06-13
K940577	Glucometer Elite Low Control	Kulzer GmbH	JJX	Class I	1994-06-13
K936304	Electrosurgical Pencil	E & M Engineering, Inc.	GEI	Class II	1994-06-13
K935805	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JTT	Class II	1994-06-13
K935546	Mac/iv Sedation Kit	Vital Signs, Inc.	BSZ	Class II	1994-06-13
K935408	Ua Perfect	Chimera Research & Chemical, Inc.	KQO	Class I	1994-06-13
K933737	Durodent Corporation Artificial Plastic Teeth	Durodent Corp.	ELM	Class II	1994-06-13
K933251	Epstein-Barr Virus Combi Test, Ebv Combi Test	Virion (U.S.), Inc.	MCD	Class I	1994-06-13
K932136	Dako Mouse Anti-Human Melanoma (Dako Anti-Hmb45)	Dako Corp.	DEH	Class II	1994-06-13
K931792	Arthroscope	Intramed Laboratories, Inc.	HRH	Class I	1994-06-13
K931146	Surgical Drapes, Modification	Amsco Sterile Recoveries, Inc.	KKX	Class II	1994-06-13
K924726	Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono Anti	Dako Corp.	DEH	Class II	1994-06-13
K942572	Volume Ventilator	Med-Plastics Intl., Inc.	BZO	Class I	1994-06-10
K942571	Hyper-Inflation Bag	Med-Plastics Intl., Inc.	NHK	Class II	1994-06-10
K942570	Mapleson D Circuit	Med-Plastics Intl., Inc.	CAI	Class I	1994-06-10
K942569	Ventilator Hose	Med-Plastics Intl., Inc.	BZO	Class I	1994-06-10
K942568	Adult Anesthesia Breathing Circuit	Med-Plastics Intl., Inc.	CAI	Class I	1994-06-10
K942567	Mass Spectrometry Monitoring Lines and Connectors	Med-Plastics Intl., Inc.	CCK	Class II	1994-06-10
K942399	Kyokko Um Series Intensifying Screen	FUJIFILM Healthcare Americas Corporation	EAM	Class I	1994-06-10
K942393	Tubli-Seal Ewt	Sybron Dental Specialties, Inc.	KIF	Class II	1994-06-10
K942053	Aesculap Interchangeable Trocar Instrument Set	Aesculap Inc	GCJ	Class II	1994-06-10
K942044	Bard Endoscopic Overtube	C.R. Bard Inc	FED	Class II	1994-06-10
K942031	Caulk Tooth Conditioner Gel and Syringe	Dentsply Intl.	EBF	Class II	1994-06-10
K941572	Fluoride-Psa Prime/adhesive	Dentsply Intl.	KLE	Class II	1994-06-10
K941452	Ultracam II	Dental Vision Direct, Inc.	EIA	Class I	1994-06-10