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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2526 of 3531

510(k) clearances, page 2526 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K902116	Modified Endobronchial Tube	Concord/Portex	BTS	Class II	1990-08-03
K902078	Add'l Indication for Octyldent 2-Octyl Cranoacry.	Crx Medical, Inc.	EMA	Class II	1990-08-03
K902050	Biolastic Super Elastic Arches	Rmo, Inc.	EJF	Class I	1990-08-03
K901594	H.n. Total Hip Prosthesis	Med-Tek Corp.	LWJ	Class II	1990-08-03
K900912	Baby E.t. Tape II	B & B Medical Technologies, Inc.	CBH	Class I	1990-08-03
K900637	Bear Cem Controller	Bear Medical Systems, Inc.	CBK	Class II	1990-08-03
K895731	Den-Mat Cerinate Porcelain	Den-Mat Corp.	EIH	Class II	1990-08-03
K903195	London Diagnostics Lumatag (R) Ige Chem. Imm Assay	London Diagnostics, Inc.	DGC	Class II	1990-08-02
K903173	Laurent Tardy	Acces Intl. Eyewear	HQZ	Class I	1990-08-02
K903122	Equate(tm) Aqr Apo Al/b Duo Control	Binax, Inc.	DFC	Class II	1990-08-02
K902997	Milenia (Tm) Ferritin	Siemens Healthcare Diagnostics Inc.	JMG	Class II	1990-08-02
K902941	Curvilinear Silicone Chin Implant	Implantech Associates Inc	FWP	Class II	1990-08-02
K902749	Olympic Mini Bili-Lite, Model 77	Olympic Medical Corp.	LBI	Class II	1990-08-02
K902735	Sd Snares	Olympus Corp.	GEI	Class II	1990-08-02
K902443	Lumatag(tm) Lh Diagnostic Kit	London Diagnostics, Inc.	CEP	Class I	1990-08-02
K902430	Glucolet 2 Automatic Lancing Device for Ob. Blood	Kulzer GmbH	FMK	Class II	1990-08-02
K902232	Weck Electrosurgical Generator #174200	Edward Weck, Inc.	GEI	Class II	1990-08-02
K901981	Abbott Modified Fact Plus Pregnancy Test	Abbott Medical	LCX	Class II	1990-08-02
K901688	Arterial/venous Bloodlines	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1990-08-02
K901368	Hemospal Kits A1, A2d, Ao, & A1d	Gambro-Hospal, Inc.	FJG	Class II	1990-08-02
K900752	Incubator 8000	Dragerwerk AG	FMZ	Class II	1990-08-02
K900624	Dobbhoff(r) Gastrotrac Jejunal Feeding System	Biosearch Medical Products, Inc.	KNT	Class II	1990-08-02
K900590	Biosearch Dobbhoff(r) Gastrotrac Jejunal Feeding	Biosearch Medical Products, Inc.	KNT	Class II	1990-08-02
K900563	Dobbhoff(r) Endoenteric Gastric Decompression Cath	Biosearch Medical Products, Inc.	KNT	Class II	1990-08-02
K900471	Fiberbraid(tm) Bonded Retainer	Uthoff Dental Mfg.	EJF	Class I	1990-08-02
K900375	Becton Dickinson Program 2 Infusion Pump	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1990-08-02
K900324	Dobbhoff Wire Guided Jejunal Feeding Tube	Biosearch Medical Products, Inc.	KNT	Class II	1990-08-02
K896717	Partner Infusion System:	Q-Life Systems, Inc.	FRN	Class II	1990-08-02
K893980	Lindquist Model 370	R.J. Lindquist Co.	IPF	Class II	1990-08-02
K892960	Lindquist Model Ss Powered Muscle Stimulator	R.J. Lindquist Co.	IPF	Class II	1990-08-02
K903212	Latex Surgical Sterile Gloves	Mirage Medical & Chemical, Inc.	KGO	Class I	1990-08-01
K903019	Modified Coag-1 Pt Test Card	Cardiovascular Diagnostic Services	GJS	Class II	1990-08-01
K902894	Post Cement (Dental Composite)	Medical Device Inspection Company	EMA	Class II	1990-08-01
K902848	Fastrecon 88 Periferal	Scientific Technology, Ltd.	JAK	Class II	1990-08-01
K902827	Anatomical Mandibular Implant Style II	Implantech Associates Inc	FWP	Class II	1990-08-01
K902826	Anatomical Mandibular Implant Style I	Implantech Associates Inc	FWP	Class II	1990-08-01
K902825	Extended Chin Implant Style II	Implantech Associates Inc	FWP	Class II	1990-08-01
K902824	Extended Chin Implant Style I	Implantech Associates Inc	FWP	Class II	1990-08-01
K902743	Degufill (Tm) Etchant Gel	Degussa AG	EBF	Class II	1990-08-01
K902458	Acs 0.02 M Calcium Chloride	Analytical Control Systems	JPA	Class II	1990-08-01
K902416	Surelite and Surelite Xl Blood Lancet	Gainor Medical Europe, Ltd.	FMK	Class II	1990-08-01
K902403	Elite r/f Spot Film Drive	Rms Div.	IXL	Class II	1990-08-01
K902316	Knee Qd Coil Mrt 50A	Toshiba America Mri, Inc.	LNH	Class II	1990-08-01
K902315	Cervical Coil Mrt 50A	Toshiba America Mri, Inc.	LNH	Class II	1990-08-01
K902310	Software Release 4.2P, Access(tm)	Toshiba America Mri, Inc.	LNH	Class II	1990-08-01
K902290	Ite Hearing Aid Model Palomino	Improved Hearing Service, Inc.	ESD	Class I	1990-08-01
K902203	Tenckhoff Peritoneal Dialysis Kit	Akcess Medical Products, Inc.	FJG	Class II	1990-08-01
K902135	Percutaneous Introducer Kit	Device Labs, Inc.	FOZ	Class II	1990-08-01
K902112	Blom-Singer(r) Tracheoesophageal Fistula Stent	Freudenberg Medical, LLC	EWL	Class II	1990-08-01
K902076	J2 Microscope	JEDMED Instrument Company	FSO	Class I	1990-08-01