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 2223 of 3531

510(k) clearances, page 2223 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932907	Playtex Ultimates Tampons	Playtex Family Products, Inc.	HIL	Class II	1994-03-07
K932873	Seac Mobile Unit by Asi Medical	ASI Medical, Inc.	EIA	Class I	1994-03-07
K932744	Flowscreen	Erich Jaeger, Inc.	BTY	Class II	1994-03-07
K932702	Ultar-Shield	Medical Resources International, Inc.	LYY	Class I	1994-03-07
K932617	Semm-Set & Curt-Set	MARKET-TIERS, Inc. d/b/a Blue Endo	GCJ	Class II	1994-03-07
K932397	Reliant	Allan Walling Medical Equipment Co.	LKY	Class II	1994-03-07
K932174	Gamma Locking Nail-Cross Locking Screws	Howmedica Corp.	KTT	Class II	1994-03-07
K931822	Carapace Pelvic Exam Trays	Carapace, Inc.	MLT	Class II	1994-03-07
K931772	Suretip Syringe Tip Cover	Western M/D, Inc.	ECB	Class I	1994-03-07
K931668	Picc Insertion Tray	Clinipad Corp.	FOZ	Class II	1994-03-07
K931585	Corfax Cardiac Data Transmitter	Ralin Medical, Inc.	DXH	Class II	1994-03-07
K931377	Safeline System IV Administration Sets & Component	Mcgaw, Inc.	FPA	Class II	1994-03-07
K930967	Baumer Staples	Baumer Ortopedia, Ltd.	JDR	Class II	1994-03-07
K926425	Amniperf(tm)	Raymart Development Co.	HGE	Class I	1994-03-07
K926420	Mast Cla Allergy System	Mast Immunosystems	DHB	Class II	1994-03-07
K926331	3.0 Fr Groshong Peripher Insert Cent Venous Cath	Bard Access Systems, Inc.	LJS	Class II	1994-03-07
K926293	Angiocor Sidehole Infusion Catheter	Angiocor	LJS	Class II	1994-03-07
K926177	Dw246 #43	Ivoclar North America, Inc.	EJT	Class II	1994-03-07
K920740	Episensor Plus	Industrias Palex C/O Dma Med-Chem Corp.	CAR	Class II	1994-03-07
K915649	Bard 500Ml Reservoir Holder	C.R. Bard Inc	FRN	Class II	1994-03-07
K914479	Microsensor Intracranial Pressure Transducer	Cerenovus, Inc.	GWM	Class II	1994-03-07
K940360	Aurolite 85	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K940343	Aurolite 1B	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K940342	Surefire W	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K940341	Aurolite 1K	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K940337	Silfree 2 High-Palladium Alloy for Porcelain Application	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K940282	Surefire 10	Argen Precious Metals, Inc.	EJT	Class II	1994-03-04
K936007	Prizm Hearing System, Model Power Bte	Audioscience, Inc.	ESD	Class I	1994-03-04
K935960	Gc Tempron	GC America Inc.	EBG	Class II	1994-03-04
K935658	Merocel(r) Turbinate Glove and Septal Splint	Merocel Corp.	LYA	Class I	1994-03-04
K935581	Omron Massager Model Hm-102	Omron Healthcare Co., Ltd.	ISA	Class I	1994-03-04
K935462	Ombron Twin-Head Massager Model Hm-101	Omron Healthcare Co., Ltd.	ISA	Class I	1994-03-04
K935459	Omron Massager Model Hm-45	Omron Healthcare Co., Ltd.	ISA	Class I	1994-03-04
K934784	Endopath Endoscopic Electrosurgical Forceps with Cutting Feature	Ethicon, Inc	GEI	Class II	1994-03-04
K934574	Model Mpft-01, Genesis	International Medical Designs, Inc.	IXR	Class II	1994-03-04
K932129	3M Autoclave Tapes	3M Company	JOJ	Class II	1994-03-04
K931460	Vectra Mobile Magnetic Resonance Imaging System	General Electric Co.	LNH	Class II	1994-03-04
K926339	Body Relaxer	Conair LLC.	ISA	Class I	1994-03-04
K926155	Ca and St	Dabi-Atlante America Corp.	EFB	Class I	1994-03-04
K926154	Handpiece Models: Ms-350;Rs-350;N-270 Air-Motor	Dabi-Atlante America Corp.	EFB	Class I	1994-03-04
K925558	Infiltube	Medsurg Industries, Inc.	HIF	Class II	1994-03-04
K923065	Baxter Personal Cycler Autommated Peritoneal Dial	Baxter Healthcare Corporation	FKX	Class II	1994-03-04
K915576	Hubuka Hyg Toothbrush	Hukuba Dental Corp.	MMD	Class I	1994-03-04
K940076	Dermassist Wet Dressing, Water	Wilshire Medical Products	FRO	Unclassified	1994-03-03
K940044	Dermassist Wet Dressing, Saline	Wilshire Medical Products	FRO	Unclassified	1994-03-03
K940005	Access Human Follicle Stimulating Hormone Assay	Bio-Rad Laboratories Inc.	CGJ	Class I	1994-03-03
K936234	Dermassist Oil Emulsion Non-Adhering Wound Dressing	Wilshire Medical Products	FRO	Unclassified	1994-03-03
K936230	Dermassist Petrolatum Gauze,usp	Wilshire Medical Products	FRO	Unclassified	1994-03-03
K935944	Proscopes and Adscopes	American Diagnostic Corp.	LDE	Class I	1994-03-03
K935880	Cedia T4 Mab Assay Modification	Microgenics Corporation	KLI	Class II	1994-03-03