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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2799 of 3530

510(k) clearances, page 2799 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871994	Ena III Test Kit (Scl-70 Autoantibody Reagents)	Behring Diagnostics, Inc.	LLL	Class II	1987-08-12
K871992	Implantable Programmable Cardiac Pulse Generators	Telectronics, Inc.	DXY	Class III	1987-08-12
K871984	Kodak Ektascan Image Trans. T1/r1 & P1 Software	Eastman Kodak Company	LMD	Class I	1987-08-12
K871859	Ct9800 Quick 3D #B7919da	General Electric Co.	JAK	Class II	1987-08-12
K871738	Osto-Pure	Clearchem Corp.	EXB	Class I	1987-08-12
K871587	The Telescan C.a.r.e. System	Telescan Medical Systems	DSH	Class II	1987-08-12
K871422	Olympus Angioscopy Pump	Olympus Corp.	DQI	Class II	1987-08-12
K871080	Peripherally Inserted Central Venous Catheter	Catheter Technology Corp.	DQY	Class II	1987-08-12
K870215	Dotter Balloon Transluminal Angio. Catheter (Poly)	Cook Inc.	LIT	Class II	1987-08-12
K872960	Clearfil Posterior New Bond	Kuraray Co.	EBF	Class II	1987-08-11
K872943	Disposable Articulator	Dentsply Intl.	EJP	Class I	1987-08-11
K872919	Omni-Tract Corral Retractor	Minnesota Scientific, Inc.	GAD	Class I	1987-08-11
K872918	Git Serum-Free Medium for Cell Culture	FUJIFILM Healthcare Americas Corporation	KIT	Class I	1987-08-11
K872917	Jinotti Suction/oxygen Insufflation Catheter	American Pharmaseal Div. Ahsc	BSY	Class I	1987-08-11
K872906	Suction Tube Tip Fits Over Bussie Frazier Tube	American Silk Sutures, Inc.	GEA	Class I	1987-08-11
K872692	Iafp P.e.a. Agar W/5% Sheep Blood	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872691	Iafp Urea Agar Slant	I.A.F. Production, Inc.	JSF	Class I	1987-08-11
K872689	Iafp Sabouraud Dextrose Agar	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872688	Iafp Mueller Hinton Agar W/5% Sheep Blood	I.A.F. Production, Inc.	LKA	Class II	1987-08-11
K872687	Iafp Mueller Hinton Agar W/hemo. W/cva Enrichment	I.A.F. Production, Inc.	LKA	Class II	1987-08-11
K872686	Iafp Mueller Hinton Agar	I.A.F. Production, Inc.	LKA	Class II	1987-08-11
K872685	Iafp Lowenstein Jensen Slant	I.A.F. Production, Inc.	KZI	Class I	1987-08-11
K872684	Iafp Campylobacter Blaser	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872683	Iafp Bile Esculin Agar	I.A.F. Production, Inc.	JSI	Class I	1987-08-11
K872682	Iafp S.s. Agar	I.A.F. Production, Inc.	JSI	Class I	1987-08-11
K872681	Iafp C.d.c. Anaerobic Agar W/5% Sheep Blood	I.A.F. Production, Inc.	JSG	Class I	1987-08-11
K872680	Iafp Hektoen Enteric Agar	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872676	Afp Middlebrook 7H10 Agar Slant	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872675	Iafp Mannitol Nacl	I.A.F. Production, Inc.	JSI	Class I	1987-08-11
K872674	Iafp Columbia C.n.a. with 5% Sheep Blood	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872673	I.a.f.p. C.d.c. Anaerobic Sheep Blood Agar W/p.e.a	I.A.F. Production, Inc.	JSJ	Class I	1987-08-11
K872672	Iafp Bile Esculin Azide Agar	I.A.F. Production, Inc.	JSI	Class I	1987-08-11
K872670	Iafp Mac Conkey Agar	I.A.F. Production, Inc.	JSH	Class I	1987-08-11
K872669	Iafp X.l.d. Agar	I.A.F. Production, Inc.	JSI	Class I	1987-08-11
K872521	Denture Cleansers	Dental Research Laboratories	JER	Class I	1987-08-11
K872464	Ion Trap Detector (Itd)	Revvity Health Sciences, Inc.	DOP	Class I	1987-08-11
K872326	Gonostat Male Specimen Collection & Transport	Technology Management & Marketing, Inc.	JTW	Class I	1987-08-11
K872319	Ln 100 Breast Marker	Instrumentation Industries, Incorporated	FTY	Class I	1987-08-11
K872234	Transcor Radio-Stethoscope Mb	Transcor, Inc.	DSH	Class II	1987-08-11
K872152	Siemens Silicone Impression Material	Siemens Hearing Instruments, Inc.	ESD	Class I	1987-08-11
K872042	Playtone Audiometer	Sensory Aids Corp.	EWO	Class II	1987-08-11
K871869	Modified Use for Model 6110A Iontophoretic Appli.	Life-Tech Intl., Inc.	EGJ	Class II	1987-08-11
K870442	Quantascope	Vital Science Corp.	DXR	Class II	1987-08-11
K870318	Amebiasis Elisa Test Kit	Lmd Laboratories	KHW	Class II	1987-08-11
K872956	Sorbitol Macconkey Agar No. 3 Cm 813	Oxoid U.S.A., Inc.	JSI	Class I	1987-08-10
K872929	Ph Monitoring System	Sensatronix Medical Systems, Inc.	FFT	Class I	1987-08-10
K872884	Look Irrigating/aspirating Cannula W/teflon Sheath	Look, Inc.	HMX	Class I	1987-08-10
K872874	Microscope Cover Glasses	Abco Dealers, Inc.	KES	Class I	1987-08-10
K872847	Solcoseryl Tissue Culture Growth Supplement	Candace Lane Corp.	KIS	Class I	1987-08-10
K872616	Bell/mckay Tracheal Tube	Sheridan Catheter Corp.	BTR	Class II	1987-08-10