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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2996 of 3529

510(k) clearances, page 2996 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851536	Philips UV-a Solarium Type Hp 3141	Philips Int'L B.V.	FTC	Class II	1985-05-01
K851535	Philips UV-a Solarium Type Hp 3140	Philips Int'L B.V.	FTC	Class II	1985-05-01
K851534	Philips UV-a Solarium Type Hp 3150	Philips Int'L B.V.	FTC	Class II	1985-05-01
K851533	Philips UV-a Sdarium Type Hp 3148(Cfr 21 Sunlamp	Philips Int'L B.V.	FTC	Class II	1985-05-01
K851469	76 Elw Bite Checker Silicone	G-C Intl. Corp.	ELW	Class II	1985-05-01
K851468	76 Ema Lining Cement	G-C Intl. Corp.	EMA	Class II	1985-05-01
K851373	Emit 700 Cannabinoid 20 Assay	Syva Co.	LDJ	Class II	1985-05-01
K851315	Abco Instrument Packs & Trays	Abco Dealers, Inc.	FRG	Class II	1985-05-01
K851314	Abco Drapes/towels	Abco Dealers, Inc.	KKX	Class II	1985-05-01
K851313	Abco Suture Removal Kits-Metal & Plastic Forceps	Abco Dealers, Inc.			1985-05-01
K851312	Abco Isolation Masks	Abco Dealers, Inc.			1985-05-01
K851264	Amer. Medical Optics Monocular Indirect Ophthalmas	American Medical Optics	HLI	Class II	1985-05-01
K851263	Amer. Medical Optic Monocular Direct Ophthalmascop	American Medical Optics	HLI	Class II	1985-05-01
K851226	i.v. Start Kit	Perry, Div.			1985-05-01
K850992	Pregna-Zyme	Armkel, LLC	JHI	Class II	1985-05-01
K850957	General Diagnostics Ticarcillin 75Mcg Suscept-Disk	Warner-Lambert Co.	JTN	Class II	1985-05-01
K850887	Dressing Change Kit	Creative Care Systems, Inc.	FOZ	Class II	1985-05-01
K850766	Zimmer Threaded Acetabular Cup	Zimmer GmbH	KWA	Class III	1985-05-01
K850631	Kirschner Orthopedic Wire, Eyelet Cerclage Wires	Kirschner Medical Corp.	JDQ	Class II	1985-05-01
K850377	Hi-Lo Tilt Table 625	Tri W-G, Inc.	INQ	Class I	1985-05-01
K850361	Synectics Ph Sys Comprising Digitrapper Mark II, E	Synectics-Dantec	FFT	Class I	1985-05-01
K850332	Kinetic 8080 Hand & Wrist Contin. Passive Machine	Richards Medical Co., Inc.	BXB	Class I	1985-05-01
K850255	Dow Corning Wright Titanium Wrist Joint Grommet	Dow Corning Corp. Healthcare Industries Materials			1985-05-01
K845006	Sun Medical Laminaria Cervical Dilator	Sun Medical Co., Ltd.	HDY	Class II	1985-05-01
K844969	Cordis Dual-Chamber Psa Model 296A (Pacemaker)	Cordis US Corp.	DTC	Class II	1985-05-01
K844829	Abdominal Pressure Control Valve	L.A.S.E.R., Inc.	HHR	Class II	1985-05-01
K844724	Fetal Telemetry System	Advantage Medical Systems, Inc.	HGM	Class II	1985-05-01
K844608	Surgicraft Copeland Disposable	A.W. Showell (Surgicraft), Ltd.	HGP	Class II	1985-05-01
K844386	Escotek-Est 301A Ultra-Sonic Unit	Nor-Am Patient Care Products, Inc.	IMI	Class II	1985-05-01
K844385	Escotek Est Trac 401	Nor-Am Patient Care Products, Inc.	ITH	Class II	1985-05-01
K851590	Mycology Agar W/antibotics	Preferred Micro-Media	JSJ	Class I	1985-04-30
K851589	Mueller Hinton Agar & Mueller Hinton Agar W/5% She	Preferred Micro-Media	JTZ	Class II	1985-04-30
K851588	Chocolate Agar	Preferred Micro-Media	KZI	Class I	1985-04-30
K851587	Thayer Martin Agar & Modified Thayer Agar	Preferred Micro-Media	JTY	Class II	1985-04-30
K851586	Macconkey Agar	Preferred Micro-Media	JSI	Class I	1985-04-30
K851585	Mannitol Salt Agar	Preferred Micro-Media	JSI	Class I	1985-04-30
K851584	Levine Emb Agar	Preferred Micro-Media	JSI	Class I	1985-04-30
K851559	Turquoise	Roseburg SA	FYA	Class II	1985-04-30
K851558	Surgical Cap Calot	Roseburg SA	FYF	Class I	1985-04-30
K851556	Op-Face Mask(masque De Chirugie)	Roseburg SA	FXX	Class II	1985-04-30
K851554	Overshoes (Surchaussures	Roseburg SA	FXP	Class I	1985-04-30
K851394	Sandare Iron Procedure	Sandare Chemical Co., Inc.	JIY	Class I	1985-04-30
K851262	Amer. Medical Optical Binocular Indirect Ophthalma	American Medical Optics	HLI	Class II	1985-04-30
K851253	Tdx Analyzer W/nephelometry Carousel	Abbott Medical	JQX	Class I	1985-04-30
K851235	Demand Oxygen Sauer Dos2 Model 10	Applied Membrane Technology, Inc.	NFB	Class II	1985-04-30
K850725	Quadra Titer Micro Plates	Microtech Medical Systems, Inc.	LIB	Class I	1985-04-30
K850591	Fiax Toxo-M Antibodies Test Kit	Intl. Diagnostic Technology	GLZ	Class II	1985-04-30
K850367	Medipart Xenon Breathing Kit Mp-02Xm-I	Medipart Jerry Alexander	IYT	Class II	1985-04-30
K850366	Medipart Xenon Breathing Kit Mp-Oixm-I	Medipart Jerry Alexander	IYT	Class II	1985-04-30
K850330	Angiotec Sc 1221 Scan Converter	Angiotec	LMA	Class II	1985-04-30