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 2026-11-05, 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 1741 of 3531

510(k) clearances, page 1741 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982951	Imtec Biopin	Imtec Corp.	DZL	Class II	1999-06-21
K991751	Status Cup Accusign Cup	Princeton BioMeditech Corp.	DKE	Class II	1999-06-18
K991716	Hispeed Nx/i CT Scanner System	GE Healthcare	JAK	Class II	1999-06-18
K991692	Chiron Diagnostics Acs: 180 Ft3	Chiron Diagnostics Corp.	CDP	Class II	1999-06-18
K991671	Hdi 5000 Diagnostic Ultrasound System	Advanced Technology Laboratories, Inc.	IYO	Class II	1999-06-18
K991518	Panatome	Dental Imaging Technologies Corporation	EHD	Class II	1999-06-18
K991318	Convergence Nua for Hitachi Spectradigital V250dsp Gamma Cameras	Hitachi Medical Corp. of America	KPS	Class II	1999-06-18
K991310	Explor-X 70	Villa Sistemi Medicali S.p.A.	EHD	Class II	1999-06-18
K991243	Norma 10	Odin Technologies, Ltd.	LNH	Class II	1999-06-18
K991047	Hardcover Condoms Male Latex Condoms, (with Spermicide)	Hardcover Products, Inc.	LTZ	Class II	1999-06-18
K991008	Dimension Bite	Espe Dental AG	ELW	Class II	1999-06-18
K990996	Genyx Medical Injection Needle	Genyx Medical, Inc.	FBK	Class II	1999-06-18
K990969	Konica Srx- 701 Automatic X-Ray Film Processor	Konica Medical Corp.	IXW	Class II	1999-06-18
K990953	Renal Link	Baxter Healthcare Corporation	KPF	Class II	1999-06-18
K990697	Rs-4V Muscle Stimulator	RS Medical	IPF	Class II	1999-06-18
K990581	Direct Hdl-Cholesterol Reagent	Kamiya Biomedical Company, LLC	LBS	Class I	1999-06-18
K990250	Hydragel Ldl/hdl Chol Direct Kit-P.n. 4005, Hydragel 7 Ldl/hdl Chol Direct Kit-P.n. 4103, Hydragel Ldl/hdl Chol Direct 0	Morax	LBT	Class I	1999-06-18
K982096	Dermastim Plus, Pigtails, Flexstim Superflex, Flexstim Plus, Carbonstim Vertastim, Enduro	Rapid Mfg. Co.	GXY	Class II	1999-06-18
K991876	Sedrite Plus Erythrocyte Sedimentation Rate	R & D Systems, Inc.	JPK	Class II	1999-06-17
K991657	Quanta Lite Ana Elisa	Inova Diagnostics, Inc.	LLL	Class II	1999-06-17
K991526	Isostar I-125 Interstitial Seed, Model Is-12501	Imagyn Medical Technologies, Inc.	KXK	Class II	1999-06-17
K991179	Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test System	Zeus Scientific LLC	DDC	Class II	1999-06-17
K990930	3D Anatomical Mesh	Santerra Medical Technology, Inc.	FTL	Class II	1999-06-17
K990925	Male Natural Rubber Latex Condom (with Lubrication)	Hardcover Products, Inc.	HIS	Class II	1999-06-17
K983922	Dried Gram-Negative and Gram-Positive Mic/combo Panels	Dade Microscan, Inc.	JWY	Class II	1999-06-17
K991898	Ultra-Select Guidewire, Hytek Guidewire	Microvena Corp.	DQX	Class II	1999-06-16
K991872	Lynx Ultrasound System	Ecton, Inc.	IYN	Class II	1999-06-16
K991858	Ssa-390A/power Vision 8000	Toshiba America Medical Systems, In.C	IYN	Class II	1999-06-16
K991498	Accuwell Total Galactose, Model 6010-Egal	Neometrics, Inc.	JIA	Class I	1999-06-16
K991406	Terumo Surflo Flex i.v. Catheter and Terumo Surflash i.v. Catheter	Terumo Medical Corp.	FOZ	Class II	1999-06-16
K990944	Osteomed Intraoral Distraction System	Osteomed	MQN	Class II	1999-06-16
K984536	Removable Cuff Abutment	Sulzer Calcitek, Inc.	DZE	Class II	1999-06-16
K991855	Conmed Stealth Non-Stick Accessory Electrode, Model 138Xxx	Conmedcorp	GEI	Class II	1999-06-15
K991811	Cordis Maxi Ds Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1999-06-15
K991675	Modification of: Sterrad Bi Test Pack	Advanced Sterilization Products	FRC	Class II	1999-06-15
K991599	Cadd Administration Set	Sims Deltec, Inc.	FPA	Class II	1999-06-15
K991425	Xantopren Comfort	Kulzer GmbH	ELW	Class II	1999-06-15
K991376	Dahedi Insulin Infusion Pump	Disetronic Medical Systems	LZG	Class II	1999-06-15
K991374	Invigra	Indus Medicare, Ltd.	HIS	Class II	1999-06-15
K991049	Climax	Medilatex Sdn. Bhd.	HIS	Class II	1999-06-15
K990949	Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas Monitoring Port	Intersurgical Ltd.	CAH	Class II	1999-06-15
K991758	Monoject Insulin Syringe	The Kendal Co.	FMF	Class II	1999-06-14
K991307	Telemedicine 2000	Card Guard Scientific Survival, Ltd.	DXH	Class II	1999-06-14
K990956	Biosensor Holter Monitor System Software, Model 1005	Biosensor Corp.	DQK	Class II	1999-06-14
K990877	Histofreezer Device	OraSure Technologies, Inc.	GEH	Class II	1999-06-14
K990859	Deflectable Tac Electrothermal Probe	Oratec Interventions, Inc.	GEI	Class II	1999-06-14
K984576	K-Pack II (Hypodermic Needle) 23G X 1, Model Kn-2325Rb, K-Pack II Needle (Hypodermic Needle) 25G X 1, Model Kn-2525Rb, K	Terumo Europe N.V.	FMI	Class II	1999-06-14
K991842	System Five/echopac with Strain Rate Imaging	GE Vingmed Ultrasound AS	IYO	Class II	1999-06-11
K991831	Bmt Anscore Health Management System, Model 1.1	Boston Medical Technologies, Inc.	DPS	Class II	1999-06-11
K991824	At Home Drug Test, Model 9171	Phamatech Inc.	MVO	Unclassified	1999-06-11