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 3464 of 3526

510(k) clearances, page 3464 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772060	Protect IV Gard	Omnicon Medical Corp.	FMP	Class I	1977-12-20
K771909	Dual Wavelength Photometer, 1177	Abbott Medical	JJQ	Class I	1977-12-20
K771823	Catheter, Cardiovascular	Usci, Div. C.R. Bard, Inc.	DYG	Class II	1977-12-20
K771737	Suction Canister	Bemis Health Care	GCX	Class II	1977-12-20
K771609	Pediatric Thyroxine Test Sys. T4	Corning Medical & Scientific	CDX	Class II	1977-12-20
K771426	Pediatric Infusion T	Quinton, Inc.	FKB	Class II	1977-12-20
K771043	Swan Ganz	Clincal Instruments Corp.	DYG	Class II	1977-12-20
K772283	Rx Pedestal Table	General Electric Co.	IZZ	Class II	1977-12-15
K772232	Liquid Nitrogen Spray Unit	Gilmore Liquid Air Co.	GEH	Class II	1977-12-15
K772224	Nerve Stimulator, Elec. Transcutaneous	Stimulation Technology, Inc.	GZJ	Class II	1977-12-15
K771445	Herpes I.d. Tm Test	Hyland Therapeutic Div., Travenol Laboratories	GQL	Class II	1977-12-14
K772237	Oxygenator, Bubble	Shiley, Inc.	DTZ	Class II	1977-12-13
K772235	Hand Control Access.-Electrosurg. Units	Cameron-Miller, Inc.	GEI	Class II	1977-12-13
K772220	Probe, Coagulation Accessory	Kli	KNF	Class II	1977-12-13
K772218	Catheter, Silicone Coated	Concord Laboratories, Inc.	EZL	Class II	1977-12-13
K772217	Temperature Monitor	Hudson Oxygen Therapy Sales Co.	FLL	Class II	1977-12-13
K772214	Ophthalmoscope, Binocular, Indirect	Varian Assoc., Inc.	HLI	Class II	1977-12-13
K772213	Lamp Delivery Sys.-Photocoagulation	Varian Assoc., Inc.	HQB	Class II	1977-12-13
K772199	Cauteries, Hot Wire, Disp.	Intermedics, Inc.	GEI	Class II	1977-12-13
K771702	Vessel-Stabilizer	Med General	KDC	Class I	1977-12-13
K771701	Vessel-Clude	Med General	GDJ	Class I	1977-12-13
K771589	Auto Suture	U. S. Surgical Corp.	GDJ	Class I	1977-12-13
K772210	Culture Collec. Trans. Sys., Double Wet	Precision Dynamics Corporation	JTW	Class I	1977-12-09
K772208	Culture Collec. Trans. Sys., Single Dry	Precision Dynamics Corporation	JTW	Class I	1977-12-09
K772206	Culture Collec. Trans. Sys., Single Wet	Precision Dynamics Corporation	JTW	Class I	1977-12-09
K772205	Culture Collec. Trans. Sys., Double Wet	Precision Dynamics Corporation	JTW	Class I	1977-12-09
K771672	Microcult-Id	Miles Laboratories, Inc.	JXA	Class I	1977-12-09
K772225	Patellar Prosthesis	Cutter Laboratories, Inc.	JWH	Class II	1977-12-08
K772200	Yasargil Aneurysm Clips	Aesculap Instruments Corp.	HCH	Class II	1977-12-08
K772182	Surgical Gown, Reinforced	Surgikos, Inc.	FYA	Class II	1977-12-08
K772178	Pacer Monitor, Pulse Width	Survival Technology, Inc.	DXH	Class II	1977-12-08
K772135	Biological/chemical Indicator	Amsco Co.	JOJ	Class II	1977-12-08
K772129	Medi-Jector	Derata Corp.	KZE	Class II	1977-12-08
K772094	Lifecare i.v. Pump - Model III	Abbott Medical	FRN	Class II	1977-12-08
K771935	Digital Thermometer	Medical Networks	FLL	Class II	1977-12-08
K771911	Plastic Stopcock W/ Extension Tube	Medon Corp.	FMG	Class II	1977-12-08
K771300	Intravenous Infusion Pump	Stewart-Naumann Laboratories	FRN	Class II	1977-12-08
K772172	Dynazyme Tm II Cardiak-Mb	J.T. Baker Chemical Co.	JHW	Class II	1977-12-06
K772157	Creatinine, 64972	Harleco	CGX	Class II	1977-12-06
K772156	Ultrachem Phosphorus, 64973	Harleco	CEO	Class I	1977-12-06
K772155	Ultrachem Total Protein, #64974	Harleco	CEK	Class II	1977-12-06
K772109	In Vitro Human Tsh Ria Test	Clinical Assays, Inc.	JLW	Class II	1977-12-06
K772106	Ph Calibration Buffers	General Diagnostics	JIT	Class II	1977-12-06
K772088	Ames T-3 Uptake Strip Test	Miles Laboratories, Inc.	KHQ	Class II	1977-12-06
K771936	Microbiological Culture Medium	Scott Laboratories, Inc.	JSH	Class I	1977-12-06
K771906	Phosphate	Simmler & Son, Inc.	CDT	Class I	1977-12-06
K771905	Glycerol Substrate	Simmler & Son, Inc.	CDT	Class I	1977-12-06
K771904	Glycerol Kinase	Simmler & Son, Inc.	CDT	Class I	1977-12-06
K771903	Lipase	Simmler & Son, Inc.	CDT	Class I	1977-12-06
K771662	Automatic Analyzer	Lachat Chemicals, Inc.	JJC	Class I	1977-12-06