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 2026-10-19, 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 3031 of 3529

510(k) clearances, page 3031 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843823	Translux Cl	Kulzer GmbH	EBZ	Class II	1984-12-04
K843738	Cab2 Computer Assisted Biofeedback	Discrete Data Systems, Inc.	HCC	Class II	1984-12-04
K843699	Bioself Tm 110	Bioself, Inc.	LHD	Unclassified	1984-12-04
K843681	Respiration & Heart Rate Monitor 530	Tri-Med, Inc.	BZQ	Class II	1984-12-04
K843627	Venesection Tray, Adult 6050	Pro-Lab, Inc.	FSM	Class I	1984-12-04
K843514	Minuteman CO2 Microsurgical Laser Oto	American Surgical Laser, Inc.	EWG	Class II	1984-12-04
K843090	University of Chicago Vascular Angiogram	Geneva Laboratories, Inc.	FPA	Class II	1984-12-04
K843056	Elastic Bandage	Sterile Medical Systems	GAX	Class I	1984-12-04
K842989	Shave Prep Kits	Biological & Environmental Control Laboratories	KME	Class I	1984-12-04
K842404	Dressing Change Tray Sterile 5002	Pro-Lab, Inc.			1984-12-04
K842209	Arm-a-Flow Intravenous Flow Regulator	Armour Pharmaceutical Co.	LDR	Class II	1984-12-04
K844349	Sr Vivodent Pe Anterior Teeth & Sr Orthotyp Re Pos	Ivoclar USA, Inc.	ELM	Class II	1984-12-03
K844329	Surflex F	G-C Intl. Corp.	ELW	Class II	1984-12-03
K844326	Occlusin Light Cured Visible Radiopaque Composite	Coe Laboratories, Inc.	EBF	Class II	1984-12-03
K844324	Tiger Band	World Wide Outdoor Marketing	DZN	Class I	1984-12-03
K844275	Starket Model Hms	Starkey Laboratories, Inc.	ETW	Class II	1984-12-03
K844238	Orapik Periodontal Scaler	Dental Concepts, LLC	JET	Class I	1984-12-03
K844069	Ta-201 Clinical Audiometer	Teledyne Avionics Div. of Teledyne	EWO	Class II	1984-12-03
K844059	Rionet Hearing Aid Hb-34As	Rion Acoustic Instruments, Inc.	ESD	Class I	1984-12-03
K844057	C-22 Pit & Fissure Sealant	Pentron Corp.	EBC	Class II	1984-12-03
K843967	Enzygnost Beta-2 Microglobulin Test	Behring Diagnostics, Inc.	JZG	Class II	1984-12-03
K843923	Thymatron	Somatics, LLC	QGH	Class II	1984-12-03
K843901	Isostatic Condenser	Shofu Dental Corp.	EKG	Class I	1984-12-03
K843618	Audiometer	Grason-Stadler, Inc.	EWO	Class II	1984-12-03
K843551	Playtex Baby Powder Deodorant Tampons	Playtex, Inc.	HIL	Class II	1984-12-03
K843355	Transducer for Kontrol 5Mhz Sigma 20	Kontron Instruments, Inc.	MHZ	Class III	1984-12-03
K843344	Active Vertical Corrector Active Bite	Active Vertical Correctors, Inc.	ECO	Class I	1984-12-03
K843171	Filafex Tm, Esthetic Orthodontic Wire	Berkley and Co.	DZC	Class I	1984-12-03
K843068	Hearing Aids 372 & 372 Ai	Telex Communications, Inc.	ESD	Class I	1984-12-03
K843033	Deseret Intravascular Catheter	Parke-Davis Co.	FOZ	Class II	1984-12-03
K842477	Credent Radiopaque Denture Resin	Credent Co.	EBI	Class II	1984-12-03
K842476	Credent Radiopaque Crown & Bride	Credent Co.	EBI	Class II	1984-12-03
K842049	Fluoroskan	Flow Laboratories, Inc.	JZT	Class I	1984-12-03
K841881	Easy Eyes Tm Lens Carrying Case	Eaton Medical Corp.	HPX	Unclassified	1984-12-03
K841653	Del Mar Avionics 5509 Neuro-Scanner	Del Mar Avionics	GWQ	Class II	1984-12-03
K841232	Pulse Generator 696, 696B & 696L	Siemens Elema AB	DXY	Class III	1984-12-03
K841230	Pulse Generator 686, 686B 686L	Siemens Elema AB	DXY	Class III	1984-12-03
K841225	Pulse Generator 689, 689B & 689L	Siemens Elema AB	DXY	Class III	1984-12-03
K844306	Gainor Medical Syringe	Gainor Medical	FMF	Class II	1984-11-30
K844305	Gainor Medical Flowmax Needles	Gainor Medical	FMI	Class II	1984-11-30
K844079	Novametrix 860 Prota. Transcutaneous Oxygen	Novametrix Medical Systems, Inc.	KLK	Class II	1984-11-30
K844017	Microtens 7757 t.e.n.s. Stimulator	Rabar, Inc.	GFJ	Class I	1984-11-30
K843949	i.v. Pump Administration Set	Travenol Laboratories, S.A.	FRN	Class II	1984-11-30
K843608	Capillary Blood Collection Tube	Medical Technomics, Ltd.	GIO	Class I	1984-11-30
K843557	K-Apatite 20-40 Mesh K-Apatite 40-60	Katecho LLC	ELE	Class II	1984-11-30
K843506	Lkb 2189 Ultroprocessor	Lkb Instruments, Inc.	IEO	Class I	1984-11-30
K843505	Lkb 2230 Rotary One	Lkb Instruments, Inc.	IDO	Class I	1984-11-30
K843202	Heparin Calibrator Aca	E.I. Dupont de Nemours & Co., Inc.	KFF	Class II	1984-11-30
K843201	Heparin Aca Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	KFF	Class II	1984-11-30
K843122	Resolve-Csf	Isolab, Inc.	DFI	Class I	1984-11-30