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 2211 of 3531

510(k) clearances, page 2211 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934880	Mti Photoscreener	Medical Technology and Innovations, Inc.	MMF	Class II	1994-04-06
K934841	Urinary/cerebrospinal Fluid Protein	E.I. Dupont de Nemours & Co., Inc.	CEK	Class II	1994-04-06
K934592	Epoc 2000 Point-of-Care Analyzer and Epoc 5-Chemistry Reagent Rotor	Abaxis Inc	JJG	Class I	1994-04-06
K934461	Non-Prescription Sunglasses	Good Bond Industrial Corp.	HQY	Class I	1994-04-06
K934135	Emit 2000 Digoxin Assay/calibrators Modification	Syva Co.	KXT	Class II	1994-04-06
K933572	Urine Heroin/morphine Direct Ria Kit (I-125)	Immunalysis Corporation	DOE	Class II	1994-04-06
K932612	Daelim Corp. Eye Wear Model	Daelim Corp.	HQZ	Class I	1994-04-06
K930678	Amylase	Horizon Diagnostics, Inc.	JFJ	Class II	1994-04-06
K923630	Phaco Needles 1000-R & 1000-O Needles	O.R. Specialties, Inc.	HQC	Class II	1994-04-06
K920302	Pace 2 Chlamydia Trachomatis Probe Confirm Assay	Hologic, Inc.	LSK	Class I	1994-04-06
K940753	Tan America Sun Up	Tan America	LEJ	Class II	1994-04-05
K940568	Document(r) Zero	Casco Standards	JJX	Class I	1994-04-05
K940194	Synermed Ise Reagents	Synermed, Inc.	JGS	Class II	1994-04-05
K935650	Cedia(r) Dau Pcp Assay	Microgenics Corporation	LCM	Unclassified	1994-04-05
K935613	Radias Monoclonal Hba 1C Assay	Bio-Rad	LCP	Class II	1994-04-05
K935218	Schuco-Vac Model 178	Schuco, Inc.	JCX	Class II	1994-04-05
K935196	Para 5 Diff	Streck Laboratories, Inc.	JPK	Class II	1994-04-05
K935088	Powder Free Gloves	Avt Rubber Products, Ltd.	LYY	Class I	1994-04-05
K933337	R and D Battery Replacement	R & D Batteries, Inc.	KIJ	Class I	1994-04-05
K931686	Malleolar Screw	Onyx Medical LLC	KTW	Class II	1994-04-05
K931682	Cannulated Malleolar Screw	Onyx Medical LLC	KWK	Class II	1994-04-05
K925818	Akcess-Cath	Akcess Medical Products, Inc.	LFJ	Class II	1994-04-05
K922613	Cl Hip Stem H/a Coated	Lima Intl. Corp.	MEH	Class II	1994-04-05
K920413	Decomat a 8666	Getinge International, Inc.	MDZ	Class II	1994-04-05
K920406	Decomat 228	Getinge International, Inc.	MDZ	Class II	1994-04-05
K940930	Aurium G14	Argen Precious Metals, Inc.	EJT	Class II	1994-04-04
K940070	Stopcock Intravenous Therapy	Puritas Health Care, Inc.	FMG	Class II	1994-04-04
K940056	Winged Infusion Set a-Port Vascular Access System	Puritas Health Care, Inc.	FPA	Class II	1994-04-04
K936190	Behind the Ear Hearing Aid	Audina Hearing Instrument, Inc	ESD	Class I	1994-04-04
K935532	Transfer Set	Puritas Health Care, Inc.	LHI	Class II	1994-04-04
K935151	Hydrocolloid Heating Unit	Centrix, Inc.	ELW	Class II	1994-04-04
K934502	Flow Spirometer	Healthdyne, Inc.	BZH	Class II	1994-04-04
K934287	Dynasound Model 401 Therapeutic Ultrasound Stimulator	Dynawave, Corp.	IMG	Class II	1994-04-04
K930682	Eztest-Steam	Sgm Biotech, Inc.	FRC	Class II	1994-04-04
K930534	Tmc I, II	Ciba Corning Diagnostics Corp.	JJY	Class I	1994-04-04
K925583	Jobskin Continuing Care	Jobst Institute, Inc.	MDA	Class I	1994-04-04
K925154	Jobst-Custom	Jobst Institute, Inc.	DWL	Class II	1994-04-04
K923162	Tbc Trauma Suit Protective Gown	Tbc, Inc.	FYC	Class II	1994-04-04
K940349	Neuromuscular Electrical Stimulator	Progressive Concepts, Inc.	IPF	Class II	1994-04-01
K940177	Otosonic Cf-2, Cf-2 Ic, Cf-2 Anf, Cf-2 with Improved Class D (Delta Amp)	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K940103	Beltone Ode and Beltone Ode Vx; Ode Clearvoice Ic and Beltone Ode Vx Clearvoice Ic; Beltone Ode Clearvoice Anf and	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K940102	Beltone Opera/opera Mhp/opera Max	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K940101	Otosonic Acs II D with Srr	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K940100	Profile Ic; Profile Clearvoice; Profile	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K940099	Otosonic (Osi) Lps D; Lps D Ic; Lps D Asp	Beltone Electronics Corp.	ESD	Class I	1994-04-01
K936209	Slit Lamp, H-201	Canon Medical Components U.S.A., Inc.	HJO	Class II	1994-04-01
K935747	Megabeam Endocular Probe	Ceram Optec, Inc.	HQF	Class II	1994-04-01
K935498	7500 Data Tower	E-Systems, Inc.	LMB	Class I	1994-04-01
K935490	Electrosurgical Device, Model 26-2500	Cameron-Miller, Inc.	GEI	Class II	1994-04-01
K935342	Scmd Keratome	S.C.M.D. Keratomes of Arizona	HNO	Class I	1994-04-01