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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3254 of 3528

510(k) clearances, page 3254 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813333	Alphatemp Clinical Thermometer	Alpha Omega Engineering Ltd.	FLL	Class II	1981-12-31
K813327	Sepcor Temperature Monitor	Separation Science Corp.	KSE	Class II	1981-12-31
K813320	Model 6200 Oxygen Concentrator	Hudson Oxygen Therapy Sales Co.	CAW	Class II	1981-12-31
K813316	Custom-in-the-Ear Hearing Aid	Telesonic, Inc.	ESD	Class I	1981-12-31
K813312	Universal Suction Pump Type Eus	Egnell, Inc.	BTA	Class II	1981-12-31
K813311	Compressor, Air, Portable	The Biomed Group	BTI	Class II	1981-12-31
K813307	Uva Hex Unit	Sun Shanty, Inc.	FTC	Class II	1981-12-31
K813273	Emergency Power Pac (Empac)	Optical Micro Systems, Inc.	HKP	Class II	1981-12-31
K813260	Tracheostomy Care Tray	E.M. Adams Co., Inc.	LDQ		1981-12-31
K813259	In-Stopper (Injection Cap	Burron Medical Products, Inc.	FPA	Class II	1981-12-31
K813248	Dental Floss Holder	Sewon Industry	JES	Class I	1981-12-31
K813243	Ceral-Base Metal Alloy	Sillard Products, Inc.	EJH	Class II	1981-12-31
K813227	Intraosseous Dental Implant	Pacific Implant, Inc.	DZE	Class II	1981-12-31
K813208	K60 Habitat Environment Enclosure	Kohler	LEJ	Class II	1981-12-31
K813207	K51,k52 Environment Enclosure	Kohler	LEJ	Class II	1981-12-31
K813202	Thermalog S Steam Sterilization Integra	Bio-Medical Sciences, Inc.	JOJ	Class II	1981-12-31
K813201	Castle #3241 Gas Aerator	Sybron Corp.	FLI	Class II	1981-12-31
K813200	Gdc-1136 Casting Alloy for Porcelain-Fu	Ney	EJS	Class II	1981-12-31
K813189	Phadebas/phadezym Ige Reagents	Pharmacia, Inc.	DGC	Class II	1981-12-31
K813164	Systek #1 Eiken	Syn-Kit, Inc.	JSS	Class I	1981-12-31
K813092	Accupro i.v. Administration Set	American Mcgaw	FPA	Class II	1981-12-31
K813084	Cystofix Suprapubic Bladder Drain Set	Burron Medical Products, Inc.	KOB	Class II	1981-12-31
K813082	Ureofix 500 Urine Measuring System	Burron Medical Products, Inc.	FFG	Class II	1981-12-31
K813074	Connectors & Adapters	Seven Harvest Intl. Import & Export	BYX	Class I	1981-12-31
K813006	Model Tds-2450-2 Microwave Diathermy Sys	Technology Applications Group			1981-12-31
K812988	Agglutex Barbiturates Test Kit	Hoffmann-La Roche, Inc.	DKN	Class II	1981-12-31
K812985	Agglutex Morphine Test Kit	Hoffmann-La Roche, Inc.	DDF	Class I	1981-12-31
K812858	Chemfil	Dentsply Intl.	EMA	Class II	1981-12-31
K812928	Vacu-Fil Transfer Set	American Pharmaseal Div. Ahsc	LHI	Class II	1981-12-30
K812901	125I Ferritin Radioimmunoassay Kit	Bio-Ria	DBF	Class II	1981-12-30
K812829	Coatest Antithrombin	Kabivitrum, Inc.	JBQ	Class II	1981-12-30
K812808	Bbl Directigen Test Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	GTY	Class I	1981-12-30
K812016	Vs600 Jet Ventilator	Instrument Development Corp.	CBK	Class II	1981-12-30
K813516	MRI Tobramycin Ria Kit	Microanalytic Research, Inc.	KLB	Class II	1981-12-29
K813514	Edslab Catheter Cover	American Edwards Laboratories	DQY	Class II	1981-12-29
K813512	Rhesus Monkey Blood in Alsever's	Dutchland Laboratories, Inc.	LHW	Class I	1981-12-29
K813508	Sac-Cel	Burroughs Wellcome Co.	KTS	Class II	1981-12-29
K813502	Narco Telecare Isoflo Pressure Monitor	Narco Bio-Systems	DRS	Class II	1981-12-29
K813501	Transcutaneous Elec. Nerve Stimulator	Empi	GZJ	Class II	1981-12-29
K813499	Omed Disposable Bulldog	Omega-Med Intl., Inc.	DXC	Class II	1981-12-29
K813472	Ls 5800 Series Liquid Scintillation	Beckman Instruments, Inc.	JJJ	Class I	1981-12-29
K813471	Line Powered Low Energy Defibrillator II	Narco Scientific	LDD	Class II	1981-12-29
K813461	Percutaneous Entry Needle, Seldinger	Ocean Medical Products, Ltd.	DRE	Class II	1981-12-29
K813444	Nihon Kohden Heart Monitors Omp 7101-02	Nihon Kohden America Inc	DRT	Class II	1981-12-29
K813442	Cefinase Tm Discs	BD Becton Dickinson Vacutainer Systems Preanalytic	JTO	Class I	1981-12-29
K813438	Pneumo Pulssor	Strom Corp.	BYI	Class II	1981-12-29
K813430	Tissue Processing Cassettes & Access	American Optical Corp.	IDL	Class I	1981-12-29
K813387	Metronidazole 80Mcg. Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1981-12-29
K813358	Gerard Medical Electrode Tester	Gerard Medical Enterprises, Inc.	KRC	Class II	1981-12-29
K813331	P51 Angioplasty Pressure Transducer	Konigsberg Instruments, Inc.	LIT	Class II	1981-12-29