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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3005 of 3529

510(k) clearances, page 3005 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850832	Campylobacter Blood-Free Selective Agar Baseq	Oxoid U.S.A., Inc.	JSJ	Class I	1985-03-29
K850679	Trypsin-Edta Solution	Hazleton Research Products, Inc.	KIT	Class I	1985-03-29
K850487	Novametrix 350 Recorder-Paper Chart Recorder	Novametrix Medical Systems, Inc.	DSF	Class I	1985-03-29
K850210	Isoenzyme Test Ld-1	Sclavo, Inc.	CFE	Class II	1985-03-29
K850116	Betasonic III	Teknar, Inc.	IYO	Class II	1985-03-29
K850097	Laser-Lyse	Hematology Marketing Assoc.	GGK	Class I	1985-03-29
K850096	Laser-Globin	Hematology Marketing Assoc.	GKR	Class II	1985-03-29
K850095	Laser-Dil	Hematology Marketing Assoc.	GIF	Class I	1985-03-29
K850094	Laser-Globin Powder	Hematology Marketing Assoc.	GKR	Class II	1985-03-29
K850054	Rianen Angiotensin I Radioimmunoassay Ki	E.I. Dupont de Nemours & Co., Inc.	CIB	Class II	1985-03-29
K843680	Uri-Val	Cenogenics Corp.	JMZ	Class I	1985-03-29
K850494	Ohmeda Biox 3700 Pulse Oximeter	GE Healthcare	DPZ	Class II	1985-03-28
K850168	Stille Scandia Operating Tables Rc 3000,1100	Stille-Werner (USA), Inc.	GDC	Class I	1985-03-28
K844863	Post-Suricular Hearing Aid Pe 600Cd	Phonic Ear, Inc.	ESD	Class I	1985-03-28
K844859	Post-Auricular Hearing Aid Model Pe 600 Ppc	Phonic Ear, Inc.	ESD	Class I	1985-03-28
K844272	Model 473-03 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844271	Model 479-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844270	Model 480-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844269	Model 483-02 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844268	Model 483-03 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844267	Model 483-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844266	Model 492-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844265	Model 495-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844264	Model 493-03 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844263	Model 493-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844262	Model 483-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844261	Model 490-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844260	Model 476-03 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K844259	Model 486-01 Pacing Lead	Intermedics, Inc.	DTB	Class III	1985-03-28
K851014	Acme Low-Profile Chair Scal 7300	Acme Medical Scale Co.	FRW	Class I	1985-03-27
K850630	Blood Oxygenator Model No. Max-5	American Bentley	DTZ	Class II	1985-03-27
K850562	Flossage - Electric Toothflosser	Mcspadden, Inc.	JEQ	Class I	1985-03-27
K850422	Ats Acoustic Standoff - Water Bag	Ats Laboratories, Inc.	ITX	Class II	1985-03-27
K850398	Nu-Cath Emergency Kit	Intl. Medical Devices, Ltd.	FOZ	Class II	1985-03-27
K850324	Elecath Open Tip Bipolar Pacing Catheter	Electro-Catheter Corp.	LDF	Class II	1985-03-27
K850186	Post Auricular Hearing Aids Star 33Pp, 44,55F &	Robert Bosch Corp.			1985-03-27
K850083	Tissue Temp Probe	Pat O. Daily	FLL	Class II	1985-03-27
K850061	Micro Volume Double Line Extension Set	Travenol Laboratories, S.A.	FPA	Class II	1985-03-27
K844970	Cordis Encor Pervenous Atrial & Ventricular Leads	Cordis US Corp.	DTB	Class III	1985-03-27
K844861	Post-Auricular Hearing Aid Model Pe 600Ppcl	Phonic Ear, Inc.	ESD	Class I	1985-03-27
K844860	Post-Auricular Hearing Aid Model Pe 600Chd	Phonic Ear, Inc.	ESD	Class I	1985-03-27
K844733	Kontron Minimon 7131 Patient Monitor	Kontron Instruments, Inc.	DRT	Class II	1985-03-27
K844732	Kontron Minimon 7132 Patient Monitor	Kontron Instruments, Inc.	DRT	Class II	1985-03-27
K844555	Pathfinder Cardiovascular Catheter	Argon Medical Corp.	DQO	Class II	1985-03-27
K850787	Solid Phase Free Estriol Enzyme Immunoassay	Nms Pharmaceuticals, Inc.	CGI	Class I	1985-03-26
K850726	Wire Cutters, Brachytherapy-Table Top & Hand Held	Syncor Intl. Corp.	IWA	Class II	1985-03-26
K850614	Sand S Mb12 Mammography Moving Grid Bucky	S & S X-Ray Products, Inc.	IZH	Class II	1985-03-26
K850571	I-125 Implant Gun	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1985-03-26
K850434	Cs137 Sealed Sources	Syncor Intl. Corp.	KXK	Class II	1985-03-26
K850397	Orbitor II Counter Balance Camera	Siemens Gammasonics, Inc.	IYX	Class I	1985-03-26