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 2013 of 3531

510(k) clearances, page 2013 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955370	Duralastic II	Allied Biomedical Corp.	MIB	Class II	1996-02-08
K955368	Duralastic I	Allied Biomedical Corp.	MIB	Class II	1996-02-08
K955334	Coulter Linearity Control	Coulter Corp.	JPK	Class II	1996-02-08
K955250	Qi Gong Massager	East Health Development Group, Inc.	IRO	Class I	1996-02-08
K955167	Surgitron	Ellman Intl., Inc.	GEI	Class II	1996-02-08
K955160	Comfort, Muscle, Cordless Massager, Battery Powered Operated Massager	Everapex Design & Marketing Corp.	IRO	Class I	1996-02-08
K955083	Verruca-Freeze Cryosurgical Delivery System (Modification)	Cryosurgery, Inc.	GEH	Class II	1996-02-08
K954924	Bactec Peds Plus Cluture Vials	Becton Dickinson Diagnostic Instrument Systems	MDB	Class I	1996-02-08
K954703	Medi-Frig	Ellman Intl., Inc.	GEH	Class II	1996-02-08
K953419	Los 3D Vision 100	Laser-Optik-Systeme GmbH & Co. KG	GCJ	Class II	1996-02-08
K953298	Ms Classique Balloon Diatation Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1996-02-08
K953055	Mistassist Breathing Exerciser	The Merlin Corp.	BWF	Class II	1996-02-08
K952535	Acufex Endobutton Tape	Acufex Microsurgical, Inc.	GAT	Class II	1996-02-08
K950849	Model #7354	Devilbiss Health Care, Inc.	BZD	Class II	1996-02-08
K950118	Abrm Catheter	Cook Inc.	FOZ	Class II	1996-02-08
K945611	Peritron	Cardio Design Pty., Ltd.	HIR	Class II	1996-02-08
K943604	Integral V Biointegrated Dental Implant System	Calcitek, Inc.	DZE	Class II	1996-02-08
K960310	Epic Introducer Sheath	North American Instrument Corp.	DYB	Class II	1996-02-07
K960196	Tri W-G, Inc Table, Tilt/exam/treatment Model 777	Tri W-G, Inc.	INQ	Class I	1996-02-07
K960189	Gel-T Cushion	Span-America Medical Systems, Inc.	KIC	Class I	1996-02-07
K955783	Vlv Sa.ef Infusion Port Extension Sets	VLV Associates, Inc.	FPA	Class II	1996-02-07
K955505	Opti-Drain Multi-Use Drainage Catheter	Navarre Biomedical, Ltd.	GBX	Class I	1996-02-07
K955399	Multidex Plus Hydrophilic Wound Dressing	Lange Medical Products, Inc.	KMF	Class I	1996-02-07
K955221	Sas Salmonella H Z38 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955220	Sas Salmonella H Z36 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955219	Sas Salmonella H Factor 7 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955218	Sas Salmonella H 1,7 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955217	Sas Salmonella H 1,2 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955216	Sas Salmonella H a Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955215	Sas Salmonella H E Complex Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955214	Sas Salmonella E,n,x Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955213	Sas Salmonella H E,n,z15 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955212	Sas Salmonella H Factor 5 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955211	Sas Salmonella H Factor 6 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955197	Sas Salmonella H Poly D Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955196	Sas Salmonella H Poly E Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K955195	Sal Salmonella H Q Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-07
K946373	Mycoplasma Slurry and Mycoplasma Crowntitre Ifa Test System	Zeus Scientific LLC	GRZ	Class I	1996-02-07
K960104	Biocclus 4	Degussa AG	EJT	Class II	1996-02-06
K955896	Macrobore Tubing - Cdc-F-1 Through Cdc-F-11	Critical Device Corp.	LHI	Class II	1996-02-06
K955870	Immulite Total Testosterone	Siemens Healthcare Diagnostics Inc.	CDZ	Class I	1996-02-06
K955647	Vidas Estradiol II (E2ii) Assay	Biomerieux Vitek, Inc.	CHP	Class I	1996-02-06
K955598	Clarus Spinepen Model 2126	Clarus Medical Systems, Inc.	GWG	Class II	1996-02-06
K955293	Fibered Platinum Coil, .035 Type	Target Therapeutics	KRD	Class II	1996-02-06
K955238	Rusch Schroeder Endotracheal Tube Style	Rusch Intl.	BSR	Class I	1996-02-06
K954783	Dryslide Cartarrhalis	Difco Laboratories, Inc.	JTO	Class I	1996-02-06
K954593	The Aircel System	Marcon Group, Inc.	FNM	Class II	1996-02-06
K954388	Conmed 2710 Cleartrace 2 Lt Monitoring ECG Electrode	Conmedcorp	DRX	Class II	1996-02-06
K954282	Ultracuff Blood Pressure Cuff and Inflation Bag	Statcorp, Inc.	DXQ	Class II	1996-02-06
K953363	Oxiflow Digital Recorder	Edentec Corp.	BZQ	Class II	1996-02-06