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 1960 of 3531

510(k) clearances, page 1960 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961359	Liquitrol-Tm, Tumor Marker Control, Level 1 and 2	Bioprocessing, Inc.	JJY	Class I	1996-09-13
K955067	Clearview C. Diff a	Unipath, Ltd.	MCB	Class I	1996-09-13
K955002	Mahurkar 8 Fr Dual Lemen Catheter	Quinton, Inc.	MPB	Class II	1996-09-13
K962991	Basis Baby-Temp Pacifier Digital Therometer	Polymedica Industries, Inc.	FLL	Class II	1996-09-12
K962853	Neosono	L.S. Scientific	LQY	Unclassified	1996-09-12
K962836	Hemagen Rheumatoid Factor Kit (Eia Method)	Hemagen Diagnostics, Inc.	DHR	Class II	1996-09-12
K962540	E-Type Contra Angle Nac-E	Nsk Nakanishi, Inc.	EGS	Class I	1996-09-12
K962520	Digital Clinical Thermometer St-813A, St-814A, St-823 and St-823A	Mesure Technology Co., Ltd.	FLL	Class II	1996-09-12
K962513	Dermaplex Hydrogel Wound Dressing	Maxxim Medical	MGQ	Unclassified	1996-09-12
K962495	Indeflator Plus 30/Plus 30 Priority Pack9with The.096 Or.115 Rotating Hemostatic Valve)	Advanced Cardiovascular Systems, Inc.	MAV	Class II	1996-09-12
K962428	Ebs (Espe Bonding System)	Espe GmbH & Co. KG.	KLE	Class II	1996-09-12
K962329	Global Loss of Resistance Syringe Glor 10	Global Medical Prods, Inc.	FMF	Class II	1996-09-12
K962274	Unicap 100	Pharmacia, Inc.	DHB	Class II	1996-09-12
K962218	Carrasyn Hydrogel Wound Dressing,carragauze Pads,carragauze Strips,carrasorb M Fdg	Carrington Laboratories, Inc.	MGQ	Unclassified	1996-09-12
K961980	Bipore Balloon Dilatation Catheter	Bipore, Inc.	LIT	Class II	1996-09-12
K961466	Percutaneous Introducer Set	Merit Medical Systems, Inc.	DYB	Class II	1996-09-12
K961376	Smart-TENS, Model 456	Bio-Medical Research, Ltd.	GZJ	Class II	1996-09-12
K961039	Bllod Port Cap, Dialysate Port Cap, Vented Dialysate Port Cap with Red Pliable Vinyl	Dayspring Medical, Inc.	FJI	Class II	1996-09-12
K960965	Front Load Injector Turret Model 859-0001/200 Ml Front Load Syringe Model 853-0211	Coeur Laboratories, Inc.	DXT	Class II	1996-09-12
K960836	Dms-9000	O.R. Solutions, Inc.	LRJ	Class I	1996-09-12
K960192	Positron Coincidence Detection	Philips North America LLC	KPS	Class II	1996-09-12
K955012	Mizuho Radiolucent Head Frame	Mizuho America, Inc.	HBL	Class II	1996-09-12
K954168	E100a Pulse Oximeter Finger Sensor/probe	Epic Medical Equipment Services, Inc.	DQA	Class II	1996-09-12
K963334	Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100	Jamieson Film Co.	IXX	Class II	1996-09-11
K962800	Stryker Universal Drill Attachments & Accessories	Stryker Corp.	HWE	Class I	1996-09-11
K962543	Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-Tu	Nsk Nakanishi, Inc.	EFB	Class I	1996-09-11
K962510	Heartport Endoaortic Clamp	Heartport, Inc.	DXC	Class II	1996-09-11
K962493	Endoscopic Clip Applier	Aesculap Inc	OCW	Class II	1996-09-11
K962442	Hytac Aplitip/hytac Osb	Espe GmbH & Co. KG.	EBF	Class II	1996-09-11
K962440	Pertac Ii/pertac II Aplitip	Espe GmbH & Co. KG.	EBF	Class II	1996-09-11
K962425	Bonopty Coaxial Bone Biopsy System with Eccentric Drill(10-1072,3,4)	Radi Medical Systems AB	GAA	Class I	1996-09-11
K962354	Diomed 15, 30, 60 Surgical Diode Laser	Lifestream Int'L, Inc.	GEX	Class II	1996-09-11
K962330	Amo Arthoscopes	American Microptiks, Inc.	HRX	Class II	1996-09-11
K962313	Modified Leveen Needle Electrode	Radiotherapeutics Corp.	JOS	Class II	1996-09-11
K962258	Endopath Endoscopic Articulating Stapler with Sweiveling Cartridge Tip	Ethicon Endo-Surgery Inc	GAG	Class II	1996-09-11
K962255	Clarus Murphypen Endoscope(2127-Xxx)	Clarus Medical Systems, Inc.	EOB	Class II	1996-09-11
K962104	Airlift Balloon Retracton System	Origin Medsystems, Inc.	GCJ	Class II	1996-09-11
K961800	Head Mounted Display	Vista Medical Technologies, Inc.	GCJ	Class II	1996-09-11
K961629	Thyroid Stiumlating Hormone (Tsh-Beads Assay) Test	Teco Diagnostics	JLW	Class II	1996-09-11
K961006	Medlite/755 Alexandrite Laser System	Continuum Biomedical, Inc.	GEX	Class II	1996-09-11
K960772	Photoderm Pl.	Esc Medical Systems, Ltd.	GEX	Class II	1996-09-11
K963191	Cedia Antibiotic Tdm Multi-Cals	Boehringer Mannheim Corp.	DKB	Class II	1996-09-10
K963181	Elecsys Calcheck T Update	Boehringer Mannheim Corp.	JJX	Class I	1996-09-10
K963158	Abbott Axsym Digitoxin (Modify)	Abbott Medical	LFM	Class II	1996-09-10
K963078	Steri-Oss Temporary Implant Cement	Steri-Oss, Inc.	EMA	Class II	1996-09-10
K963047	Air-Conduction Hearing Instruments: Models = 227, 229, 232, 216, 216P, 123, 219 (Modify)	Fenwick Hearing Instruments	ESD	Class I	1996-09-10
K962895	Dsl Dhea-S-7	Diagnostic Systems Laboratories, Inc.	JKC	Class I	1996-09-10
K962712	Ysanpoint) (Menstrual) Digital Tampon	Talbot S. Lindstrom	HEB	Class II	1996-09-10
K962664	Electra 1800C Automatic Coagulation Analyzer	Medical Laboratory Automation Systems, Inc.	GKP	Class II	1996-09-10
K962516	Tap Anti-Snoring Device	Medtronic, Inc.	LRK	Class II	1996-09-10