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 3422 of 3526

510(k) clearances, page 3422 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781750	Mirror Warmer	Arleton Technical Products, Inc.	KAI	Class I	1979-01-17
K780885	Cordia R	Cordis US Corp.	GOL	Class II	1979-01-17
K780731	Lidocaine Calibrator Kit	Vitek Systems, Inc.	DLJ	Class II	1979-01-17
K790022	Disposable Holder for Bioprosthesis	Edwards Laboratories	DTJ	Class I	1979-01-15
K782131	Pulsetaker	Van, Cott, Bagley, Cornwall & Mccarth	DRT	Class II	1979-01-15
K782105	Catheters, H-H Ventricular	Holter-Hausner Intl.	JXG	Class II	1979-01-15
K782087	Lead, Sutureless Myocardial	Daig Corp.	DTB	Class III	1979-01-15
K781819	Post Extra Systolic Potentiator	Medrad, Inc.	DQO	Class II	1979-01-15
K781517	Automatic Blood Pressure Device	Welch Allyn Inc	DXN	Class II	1979-01-11
K782173	Surgery Brush	Dexide, Inc.	GEC	Class I	1979-01-10
K782172	Brush/sponge, Disposable	Dexide, Inc.	GEC	Class I	1979-01-10
K782125	Ria Kit, Kanamycin	Siemens Healthcare Diagnostics Inc.	KJI	Class II	1979-01-10
K782123	Multiplicity of Products	Depuy, Inc.	HRS	Class II	1979-01-10
K782099	Ria Test, Nordicalb Hpl	Nordiclab Intl.	JMF	Class II	1979-01-10
K782092	Armboard Cver, Disposable	Anago, Inc.	FSE	Class I	1979-01-10
K782091	Stockinette, Disposablesurgical	Anago, Inc.	KKX	Class II	1979-01-10
K782084	Emit Procainamide Control Set	Syva Co.	LAS	Class I	1979-01-10
K782046	C-Cord	Concept, Inc.	FFZ	Class II	1979-01-10
K782045	Monitor Hs7	Scientific & General Pty., Ltd.	BZQ	Class II	1979-01-10
K782044	Monitor Hs8	Scientific & General Pty., Ltd.	BZQ	Class II	1979-01-10
K782014	Analyzer Aba-200	Abbott Medical	JJE	Class I	1979-01-10
K782010	Hormone Kit, Parathyroid	Nichols Institute Diagnostics	CEW	Class II	1979-01-10
K781959	Surgical Gowns, Sheets	Convertors	KKX	Class II	1979-01-10
K781958	Analytical Test Pack, Carbamazepine	E.I. Dupont de Nemours & Co., Inc.	KLT	Class II	1979-01-10
K781957	Analytical Test Pack, Primidone	E.I. Dupont de Nemours & Co., Inc.	DJD	Class II	1979-01-10
K781956	Cryosurgical Device 2000	Medtronic, Inc.	GEH	Class II	1979-01-10
K781946	Ria Kit, Ferritin Solid Phase	BD Becton Dickinson Vacutainer Systems Preanalytic	JMG	Class II	1979-01-10
K781939	Reagent Kit, Triglycerides	Beckman Instruments, Inc.	CDT	Class I	1979-01-10
K781938	Ria Kit, Gammadab Estriol	Clinical Assays, Inc.	CGI	Class I	1979-01-10
K781915	Data Module	Waters Assoc., Inc.	KIE	Class I	1979-01-10
K781909	Calcitonin 125	Cambridge Nuclear Radiopharmaceutical	JKR	Class II	1979-01-10
K781897	Stat Kit, Microprotein	Pierce Chemical Co.	CEK	Class II	1979-01-10
K781888	Assay System, Ferritin I Kit	New England Nuclear	JMG	Class II	1979-01-10
K781844	Ferritin Kit	Ria Products, Inc.	JMG	Class II	1979-01-10
K781782	Bun	Gilford Diagnostics	CDQ	Class II	1979-01-10
K781781	Heparsorb	General Diagnostics	GJA	Class II	1979-01-10
K782148	Hr Unit	Parke-Davis Co.	IQP	Class I	1979-01-08
K782112	Pads, Mini, Maxi	Intl. Playtex, Inc.	HHD	Class I	1979-01-08
K782111	Pads, Mini, Maxi Deodorant	Intl. Playtex, Inc.	HHL	Class II	1979-01-08
K781997	Autorange	Tri W-G, Inc.	ISD	Class II	1979-01-08
K781879	Heater, Oximeter System	Oximetrix, Inc.	DQA	Class II	1979-01-08
K782144	Disposable Surgical Instrument Tip	Anago, Inc.	KCT	Class II	1979-01-05
K782127	Stimulator, Electrical Nerve	Somatronics, Inc.	GZJ	Class II	1979-01-05
K781873	Recorder, Strip Chart with Printer	Midwest Analog & Digital, Inc.	DSF	Class I	1979-01-05
K781867	Writer, Gemini-3	C-V Monitors Corp.	DSF	Class I	1979-01-05
K781855	Lvv Option	Honeywell, Inc.	DXG	Class II	1979-01-05
K782089	Monitor, Heart Rate Model 103	Roche Medical Electronics, Inc.	DRT	Class II	1979-01-04
K782088	Monitor, Heart Rate Model 105	Roche Medical Electronics, Inc.	DRT	Class II	1979-01-04
K782069	Tray, Auxillary Block	Pharmaseal Div., Baxter Healthcare Corp.	CAZ	Class II	1979-01-04
K782104	Paste, Pro Care Prophylaxis	Young Dental Manufacturing Co 1, LLC.	FZE	Class II	1979-01-03