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 2026-10-22, 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 2966 of 3529

510(k) clearances, page 2966 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853230	Apl Mycobiotic Agar	Apl Medical Supplies	JSJ	Class I	1985-08-19
K853229	Apl 6.5% Sodium Chloride Broth	Apl Medical Supplies	JSI	Class I	1985-08-19
K853228	Apl Salmonella-Shigella Agar	Apl Medical Supplies	JSI	Class I	1985-08-19
K853227	Apl Phenylethyl Alcohol Agar(with 5% Sheep Blood)	Apl Medical Supplies	JSJ	Class I	1985-08-19
K853226	Apl Biggy Agar(nickerson)	Apl Medical Supplies	JSI	Class I	1985-08-19
K853225	Apl Levine Emb Agar	Apl Medical Supplies	JSI	Class I	1985-08-19
K853208	125I Estradiol Direct Radioimmunoassay	Travenol Laboratories, S.A.	CHP	Class I	1985-08-19
K853086	Secondary Administration Set	Lyphomed, Inc.	FPA	Class II	1985-08-19
K852997	Rapi - Staph	Advanced Medical Technology, Inc.	JWX	Class I	1985-08-19
K852987	Cariescreen - Sm	Pharma-Medica of Scandinavia, Ltd.	JSJ	Class I	1985-08-19
K852986	Glyco-Sep/alc Test Kit for Separat of Hemoglobin	Clinical Technology Inc.	LCP	Class II	1985-08-19
K852967	General Diagnostics' Ceftriaxone 30Mcg Susdep Disk	Warner-Lambert Co.	JTN	Class II	1985-08-19
K852873	Ceftazidime 30Mcg. Seni-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1985-08-19
K852689	General Diagnostics Ceftazidime 30 Mcg Susc Disk	Warner-Lambert Co.	JTN	Class II	1985-08-19
K852564	Copal Ua-512 Digital Blood Pressure Monitor	Takeda Medical, Inc.	DXN	Class II	1985-08-19
K852185	Respiratory Syncytial Virus Direct Fluorescent Ant	Bartels Immunodiagnostic Supplies, Inc.	LKT	Class I	1985-08-19
K852132	Model 21225A Cw Coppler/imaging Transducer	Hewlett-Packard Co.	ITX	Class II	1985-08-19
K851989	Dome, Disposable, Sterile	Transamerica Delaval, Inc.	DRS	Class II	1985-08-19
K851916	Vsm Models a & B	Physio Control, Inc.	DRT	Class II	1985-08-19
K851818	Sartorius Mini Sart Fh 16592	Sartorius Filters, Inc.	FPB	Class II	1985-08-19
K851817	Sartorius Mini-Sart Fh 16555	Sartorius Filters, Inc.	FPB	Class II	1985-08-19
K851816	Sartorius Minisart Fh 16534	Sartorius Filters, Inc.	FPB	Class II	1985-08-19
K851504	Vdrl Carbon Antigen Test S900500, S900250 & S90010	Ncs Diagnostics, Inc.	GMP	Class II	1985-08-19
K850837	Medipart Face Mask & Filter Mp-30Xm-I	Medipart Jerry Alexander	IYT	Class II	1985-08-19
K850836	Medipart Face Mask Mp-Xm-I	Medipart Jerry Alexander	IYT	Class II	1985-08-19
K844845	Espe Ketac-Bond	Espe GmbH (US)	EBD	Class II	1985-08-19
K841967	Deseret Thermodilution Cardiac Output	Parke-Davis Co.	DXG	Class II	1985-08-19
K840717	Ecs 502	Robert Bosch Corp.	DRT	Class II	1985-08-19
K853396	Multicap Multigas Capnometer Pb252	Instrumentarium Corp.	CCK	Class II	1985-08-16
K853275	Click Lock Multi-Vas Infection Control Manifold	Abbott Medical	FMG	Class II	1985-08-16
K853052	Integrity	Dentsply Intl.	EBG	Class II	1985-08-16
K853002	Bisfil-Ii(chemical Curable Posterior/anterior)	Bisco, Inc.	EBF	Class II	1985-08-16
K853001	Bisfil-M(light Curable Anterior Composite)	Bisco, Inc.	EBF	Class II	1985-08-16
K852981	Preformed Tooth Arch	Swipes Dental Laboratory	ELM	Class II	1985-08-16
K852882	Maxifill Transfer Set	Lyphomed, Inc.	LHI	Class II	1985-08-16
K852881	Vented Secondary IV Administration Set	Lyphomed, Inc.	FPA	Class II	1985-08-16
K852778	Bottle Decanter	Advance Medical Designs Inc	KPE	Class II	1985-08-16
K852777	Bag Decanter	Advance Medical Designs Inc	KPE	Class II	1985-08-16
K852745	Porcelain Veneer System Bonding Kit	The S. S. White Co.	EBF	Class II	1985-08-16
K852744	Characterizer Kit Visible Light Cured Restor-Color	The S. S. White Co.	EBF	Class II	1985-08-16
K852587	Cdsa(color Density, Spectral Arrray)	Tracor Northern, Inc.	OLT	Class II	1985-08-16
K852575	Waldmann F85/100w Puva	Sylvania Lighting Products	KGL	Class II	1985-08-16
K852454	Craftemp Et 3045 Electronic Thermometry System	Gambro, Inc.	FLL	Class II	1985-08-16
K852153	The P.c.a. Two-Piece Snap Lock Acetabular Cup	Howmedica Corp.	JDI	Class II	1985-08-16
K852098	Dahlberg Model US Spectrum in-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1985-08-16
K852052	Hearing Aid(all in the Ear(all in the Canal	Penn-Tech Laboratories	ESD	Class I	1985-08-16
K851988	Administration Set	Transamerica Delaval, Inc.	DRS	Class II	1985-08-16
K851987	Flush Device, Automatic	Transamerica Delaval, Inc.	DRS	Class II	1985-08-16
K851947	Ptca Guiding Catheter	Cordis US Corp.	DYB	Class II	1985-08-16
K844566	Icp Monitor Model 1000	Advanced Ultrasonic Testing & Research Corp.	GWM	Class II	1985-08-16