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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3409 of 3526

510(k) clearances, page 3409 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K790802	Essar Tourniquet for Venipuncture	Stewart Research, Inc.	GAX	Class I	1979-05-01
K790745	_Model Wc-1 Behind-the-Ear Hearing Aid	Starkey Laboratories, Inc.	ESD	Class I	1979-05-01
K790729	Octagonal Aluminum Framing System	Mizuho Orthopedic Systems Inc	HST	Class I	1979-05-01
K790727	Behind-the-Ear, Model H37d	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-05-01
K790726	Behind-the-Ear Hearing Instrument, H54	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-05-01
K790700	Behind-the-Ear Hearing Instrument, H56	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-05-01
K790697	Model H58-Behind-the-Ear Hearing Instr.	Marcon Hearing Instruments, Inc.	ESD	Class I	1979-05-01
K790641	Gdc-685	Deringer-Ney, Inc.	EJS	Class II	1979-05-01
K790640	Howmedica Brass Center Disc	E.C. Moore Co.	EHJ	Class I	1979-05-01
K790627	Lombard-Dowell Deoxyrilbonucleric Acid	Anaerobe Systems	JSH	Class I	1979-05-01
K790625	Peptone-Yeast Extract Broth	Anaerobe Systems	JSC	Class I	1979-05-01
K790552	As7 & As8 Monitors	Narco Air-Shields	DRT	Class II	1979-05-01
K790522	Coulter Accu-Zyme II Gpt Reagent	Coulter Electronics, Inc.	CKA	Class I	1979-05-01
K790492	Sero-Stat Streptococcus Test	Scott Laboratories, Inc.	GTZ	Class I	1979-05-01
K790474	Szamyl 6.5	Worthington Diagnostic Systems	CIJ	Class II	1979-05-01
K790343	Data-Zyme Ck Calorimetric/uv Procedure	Data Medical Associates, Inc.	JHS	Class II	1979-05-01
K790308	Disposable Dialyzers, Sd-Id, Sd-2D	Bentley Laboratories, Inc.	FJI	Class II	1979-05-01
K790833	Visio-Bond	Espe GmbH (US)	KLE	Class II	1979-04-30
K790832	Ketac Applic-Capsules	Espe GmbH (US)	EMA	Class II	1979-04-30
K790659	Infant Scale Disposable Liner	Hydro-Med Products, Inc.	KME	Class I	1979-04-30
K790574	Epic D215	National Patent Development Corp.	FPA	Class II	1979-04-30
K790471	Jelco* Disc Filter-0.2 Micron	Jelco Laboratories	FPB	Class II	1979-04-30
K790424	Flu-Ven 01510	Venospital, Inc.	FPA	Class II	1979-04-30
K790408	T-Connector	Medex, Inc.	FPA	Class II	1979-04-30
K790077	Biostil # 3884	Venospital, Inc.	FPA	Class II	1979-04-30
K790785	Model M25rl, (Crc) Oxygen Analyzer	Catalyst Research Corp.	CCL	Class II	1979-04-27
K790784	Model M25r, Oxygen Analyzer	Catalyst Research Corp.	CCL	Class II	1979-04-27
K790744	Lung Function Amplifier Exerciser	Empire Plastics Manufacturer	BWF	Class II	1979-04-27
K790765	Multigraph	Siemens Corp.	IZF	Class II	1979-04-26
K790764	Pacemakers without Silastic Coating	Telectronics, Inc.	DXY	Class III	1979-04-26
K790742	Ks-78 Vertical Wall Cassette Holder	Pausch Corp.	IXY	Class I	1979-04-26
K790741	Compact System	Pausch Corp.	KPR	Class II	1979-04-26
K790740	Bs 66, Universal Bucky Stand	Pausch Corp.	KPR	Class II	1979-04-26
K790739	Quinton Model 530X ECG Data Cart	Quinton, Inc.	DPS	Class II	1979-04-26
K790736	Emit-Tox Serum Benzodiazepine Assay	Syva Co.	JXM	Class II	1979-04-26
K790730	Ndm Paper Tape ECG Electrode	Ndm Corp.	DRX	Class II	1979-04-26
K790654	Closed Wound Vacuum Drainage System	3M Company	GCY	Class I	1979-04-26
K790644	Submax	Chase Mfg. Co.	DRT	Class II	1979-04-26
K790531	Anus Stimulator	Maddak, Inc.	ILS	Class I	1979-04-26
K790477	Ty Ria Kit, Automated Assay System	E. R. Squibb & Sons, Inc.	CDX	Class II	1979-04-26
K790297	Detection System, Ms-2 Electrochemical	Abbott Medical	JTA	Class I	1979-04-26
K790663	Model 1750 Standing Urinal	Life-Tech Instruments, Inc.	FFG	Class II	1979-04-24
K790551	Transport Incubator	Narco Air-Shields	FPL	Class II	1979-04-24
K790409	Low Dead Space Insulin Syringe	Pharmaseal Div., Baxter Healthcare Corp.	FMF	Class II	1979-04-24
K790763	Maxi-Vac Tm	Med General	GCY	Class I	1979-04-23
K790743	Coordinatus, Horizontal Radiographoc	Pausch Corp.	KXJ	Class II	1979-04-23
K790692	Televix	General Electrical Espanola, S.A.	KXJ	Class II	1979-04-23
K790688	Mevatron 67	Siemens Medical Laboratories, Inc.	IYE	Class II	1979-04-23
K790685	Posi-Tot	Victoreen, Inc.	KPR	Class II	1979-04-23
K790664	Model 1309 Audio Monitor	Life-Tech Instruments, Inc.	IKN	Class II	1979-04-23