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 2014 of 3531

510(k) clearances, page 2014 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K952847	Normed Bidirectrional/multidirectional Jaw Distractor	Ace Surgical Supply Co., Inc.	MQN	Class II	1996-02-06
K952687	Panalok Wedge Absorable Suture Anchor System	Ethicon, Inc	MAI	Class II	1996-02-06
K952517	Quickvue One-Step Helicobactor Pylori Test	Ortho-Clinical Diagnostics, Inc.	LYR	Class I	1996-02-06
K952186	Hsw Gmbh Hysteroscopes & Accessories	Henke-Sass Wolf, GmbH.	HIH	Class II	1996-02-06
K950306	Imtec Biobarrier	Imtec Corp.	LYC	Class II	1996-02-06
K950087	Lot 440	Medical Instruments Corporation Mic AG	FFT	Class I	1996-02-06
K955769	Access Progesterone Assay	Bio-Rad Laboratories Inc.	JLS	Class I	1996-02-05
K955527	General Use Synthetic Sponge (Sterile)	Igenics, Inc.	EFQ	Unclassified	1996-02-05
K955504	Qbc Accuread System	Becton Dickinson Diagnostic Instrument Systems	GKZ	Class II	1996-02-05
K955500	Fms Arthoprobe	Future Medical Systems, Inc.	HRX	Class II	1996-02-05
K955165	Synthetic Sponge	Igenics, Inc.	EFQ	Unclassified	1996-02-05
K955153	Lyphochek Benzo/tca Control-Set B	Bio-Rad	DIF	Class I	1996-02-05
K955103	3M No Sting Barrier Film	3M Medical Products Group	KMF	Class I	1996-02-05
K955099	Sorbie Total Elbow System	Wrightmedicaltechnologyinc	JDB	Class II	1996-02-05
K954898	Predicta Erythropoietin Kit (Modification)	Genzyme Corporation	GGT	Class II	1996-02-05
K954872	Candela Cryo-Probe Holder	Candela Corporation	GEH	Class II	1996-02-05
K954727	Slt Multidimensional Contact Laser System (Modification)	Surgical Laser Technologies, Inc.	GEX	Class II	1996-02-05
K954632	Siemens Sc 9000 Etco2 Module	Siemens Medical Solutions USA, Inc.	CCK	Class II	1996-02-05
K953968	Aesculap Power Systems (Elan-E & Microtron)	Aesculap Inc	HWE	Class I	1996-02-05
K953853	Iamin Gel Wound Dressing	Procyte Corp.	MGQ	Unclassified	1996-02-05
K953585	Schwartz Electro-Optices, Inc. Trilase 2100/20 Holmium Laser	Schwartz Electro-Optics, Inc.	GEX	Class II	1996-02-05
K953274	Genesis Porous Tibial Trays & Revision Knee System	Smith & Nephew Richards, Inc.	JWH	Class II	1996-02-05
K943367	Il Test Cholinesterase	Instrumentation Laboratory Co.	DIH	Class I	1996-02-05
K955867	Resound Personal Hearing System Bt247	Resound Corp.	ESD	Class I	1996-02-02
K955801	Radifocus Glidewire Gt with Gold Coil,glidewire Gold	Terumo Medical Corp.	DQX	Class II	1996-02-02
K955692	Finetone Fsc,	Finetone Hearing Instruments	ESD	Class I	1996-02-02
K955288	Hearing Aid Impression Material	Crown Delta Corp.	ESD	Class I	1996-02-02
K955264	Nova Chemistry Controls, Levels 1 and 2	Nova Biomedical Corporation	JJY	Class I	1996-02-02
K955260	Nova Chemistry Performance Check Solution	Nova Biomedical Corporation	JJY	Class I	1996-02-02
K955257	Ss102 Dual Channel Sep Stimulator	Axon Systems, Inc.	GWF	Class II	1996-02-02
K955252	Nova Chemistry Linearity Set F, Levels 1, 2, 3, and 4	Nova Biomedical Corporation	JJY	Class I	1996-02-02
K955210	Sas Salmonella H F,g, Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955209	Sas Salmonella H G,m Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955208	Sas Salmonella H H Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955207	Sas Salmonella H I Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955206	Sas Salmonella H K Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955205	Sas Salmonella H L,v Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955204	Sas Salmonella H L,w Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955203	Sas Salmonella H L,z13 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955202	Sas Salmonella H L,z40 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955201	Sas Salmonella H,m,t, Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955200	Sas Salmonella H Poly a Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955199	Sas Salmonella H Poly B Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955198	Sas Salmonella H Poly C Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955194	Sas Salmonella H R Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955193	Sas Salmonella H S Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955192	Sas Salmonella H T Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955191	Sas Salmonella H X Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955190	Sas Salmonella H Y Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02
K955189	Sas Salmonella H Z Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-02