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 2026-10-05, 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 3502 of 3526

510(k) clearances, page 3502 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770122	Prostate Biopsy Needle	Cook, Inc.	KNW	Class II	1977-01-26
K770118	Carpenter Bone Clamp	Stryker Corp.	HXD	Class I	1977-01-26
K770072	Bio Trol-T Triolein Solutions	Boehringer Mannheim Corp.	JIS	Class II	1977-01-26
K770062	Gdh-Glucose (Rate) Reagent Kit	Beckman Instruments, Inc.			1977-01-26
K770049	Ldh Isotrol T	Sigma Chemical Co.	JJT	Class I	1977-01-26
K770026	Flourometer/densitometer Model 720	Corning Medical & Scientific	JQT	Class I	1977-01-26
K761158	Fluid Dispensing System	Pharmaseal Div., Baxter Healthcare Corp.	FMF	Class II	1977-01-26
K761136	Glucose Analyzer 2 W/ Choles. Reag Kt	Beckman Instruments, Inc.	CHH	Class I	1977-01-26
K761083	Bard Urine Meter W/ Bag	C.R. Bard Inc	EXR	Class II	1977-01-26
K761065	Neonatal Resuscitator, Samson	Dem Medical, Inc.	BTM	Class II	1977-01-26
K761032	Cradling System	Medin Corp.	FLE	Class II	1977-01-26
K761018	Surgical Light - Challenge 22 Series	Amsco Co.	FQP	Class II	1977-01-26
K760972	Tycos Diagnostic Penlight	Taylor Instrument Analytics Co.	KYT	Class I	1977-01-26
K760966	Catheter, Umbilical Artery	Sherwood Medical Industries	FOS	Class II	1977-01-26
K760927	Stoma Shield Adapter	Rudolfo T. Sanchez	EXE	Class I	1977-01-26
K770105	Shepard II, Lens Forcep W/ Lock	Edward Weck, Inc.	HNR	Class I	1977-01-25
K770103	Hook, Iris, Shepard U-Shaped	Edward Weck, Inc.	HNQ	Class I	1977-01-25
K770101	Shepard Lens Forcep W/ Irrigator & Lock	Edward Weck, Inc.	HNR	Class I	1977-01-25
K770080	Baker Mobile Traction	Orthopedic Equipment Co., Inc.	HST	Class I	1977-01-25
K770079	Kessell Total Shoulder	Orthopedic Equipment Co., Inc.			1977-01-25
K770073	Primus Inter Paresechocardiography Sys.	Rohe Scientific Corp.	DXK	Class II	1977-01-25
K770067	Cyanobond	Parker Laboratories, Inc.	EMA	Class II	1977-01-25
K770013	Pipetting Devices	Kensington Scientific	JQW	Class I	1977-01-25
K761320	Glucose Kit	Environmental Chemical Specialties	CFR	Class II	1977-01-25
K761284	Unival Control Cells	Dade, Baxter Travenol Diagnostics, Inc.	KSF	Class II	1977-01-25
K761089	Glucose Analyzer W/ Cholesterol Reag Kit	Beckman Instruments, Inc.	CHH	Class I	1977-01-25
K761061	Blood-Urea-Nitrogen (Bun) Analyzer 2	Beckman Instruments, Inc.	CDS	Class II	1977-01-25
K761060	Glucose Analyzer 2	Beckman Instruments, Inc.	CGA	Class II	1977-01-25
K770109	Enamelite Enamel Coating	Lee Pharmaceuticals	EBF	Class II	1977-01-24
K770104	Binkhorst Lens Forceps W/out Irrigator	Edward Weck, Inc.	HNR	Class I	1977-01-24
K770102	Hershman Lens Forceps W/out Irrigator	Edward Weck, Inc.	HNR	Class I	1977-01-24
K770100	Binkhorst Lens Forcep W/ Irrigator	Edward Weck, Inc.	HNR	Class I	1977-01-24
K770099	Shepard Lens Forcep W/ Irriga W/out Lock	Edward Weck, Inc.	HNR	Class I	1977-01-24
K770098	Hook, Iris, Hershman	Edward Weck, Inc.	HNQ	Class I	1977-01-24
K770097	Hershman Lens Forceps with Irrigator	Edward Weck, Inc.	HNR	Class I	1977-01-24
K770093	Dental Burs	The S. S. White Co.	EJL	Class I	1977-01-24
K770091	Emergency Fast-Fix Denture Repair Kit	Mr. Clarence Hurst	EBO	Class II	1977-01-24
K770060	X-Ray Positioning Device	Robert R. Moore	KPR	Class II	1977-01-24
K770094	Fluoricon 500 Image Intensifiers	General Electric Co.	EAM	Class I	1977-01-21
K770085	Robbett Microsurgical Laryngoscope	Edward Weck, Inc.	EQN	Class II	1977-01-21
K770070	Enit Aba Thyroxine Assay	Syva Co.	KLI	Class II	1977-01-21
K761015	Market Castle Unisphere	Castle Co.	FRC	Class II	1977-01-21
K760738	Automatic Electronic Sphygmomanometer	Medical Monitors, Inc.	DXN	Class II	1977-01-21
K760214	Stimulator, Pneumatic	O. F. Anderson			1977-01-21
K770069	Digoxin Clasp Tm Ria Kit	E. R. Squibb & Sons, Inc.	DPO	Class II	1977-01-18
K770054	Mirror, Naso-Pharynx	Welch Allyn Inc	KAI	Class I	1977-01-18
K770053	Mirror, Laryngeal	Welch Allyn Inc	KAI	Class I	1977-01-18
K770008	Mpx 125	General Electric Co.	IZO	Class I	1977-01-18
K770007	Mpx 100	General Electric Co.	IZO	Class I	1977-01-18
K770006	Mpx 80	General Electric Co.	IZO	Class I	1977-01-18