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 2351 of 3531

510(k) clearances, page 2351 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922909	Medical Battery Packs	Access / God Loves You	FRN	Class II	1992-09-23
K922699	Du Pont Aca Mass Creative Kinase Mb (Mckmb) Calibr	E.I. Dupont de Nemours & Co., Inc.	JIS	Class II	1992-09-23
K922523	Bipolar Electrosurgical Probes & Instruments	Ximed Medical Systems	GEI	Class II	1992-09-23
K922035	Glucose 3	Caro Med, Inc.	CGA	Class II	1992-09-23
K921674	Lifeport Infusion Set and Infusion Set W/ Y Site	Strato Medical Corp.	FPA	Class II	1992-09-23
K921664	Bio-Guard Latex Surgical Gloves	Network Medical Systems, Inc.	KGO	Class I	1992-09-23
K921578	Titan Gel Alkaline Phosphatase (Hr)	Helena Laboratories, Corp.	CIN	Class II	1992-09-23
K921449	New Stachrom Antiplasmin	American Bioproducts Co.	GGP	Class II	1992-09-23
K921222	Force 1C	Medtronic, Inc.	HGI	Class II	1992-09-23
K921054	Kendall Mod. Pediatric Ultramer Polyurethane Cath.	Kendall Healthcare Products Co. Div.Of Tyco Health	KOD	Class II	1992-09-23
K920695	Ureteral Stent	Applied Urology, Inc.	FAD	Class II	1992-09-23
K915569	Umbilical Clamp	Gam Industries, Inc.	HFW	Class II	1992-09-23
K914916	Alpine V	Mountain Medical Equipment, Inc.	CAW	Class II	1992-09-23
K924129	Miles Auto Meth Determin of Uric Acid in Urine	Kulzer GmbH	KNK	Class I	1992-09-22
K923765	Systemate Uricacid Test, Technicon Ra 1000	Em Diagnostic Systems, Inc.	CDO	Class I	1992-09-22
K923764	Systemate Phosphorus Test Technicon Ra 1000	Em Diagnostic Systems, Inc.	CEO	Class I	1992-09-22
K923593	Hemochron/factor VI Fibrinogen Assay and Cont Plas	Accriva Diagnostics, Inc.	KQJ	Class II	1992-09-22
K923414	Synermed 600 Nm Uric Acid Reagent Kit	Synermed, Inc.	KNK	Class I	1992-09-22
K923371	Autostat Anti-Thyroid Microssomal	Cogent Diagnotics, Ltd.	JNL	Class II	1992-09-22
K923370	Autostat Anti-Thyroglobulin	Cogent Diagnotics, Ltd.	JNL	Class II	1992-09-22
K923342	Microbact Solid Plate Systems	Radiometer America, Inc	JJS	Class I	1992-09-22
K923121	Qbc Hemacan Hematology System	BD Becton Dickinson Vacutainer Systems Preanalytic	GKL	Class II	1992-09-22
K923037	Miles Sodium Method	Kulzer GmbH	JOS	Class II	1992-09-22
K923022	Instrumentarium Mega4 Ht	Instrumentarium Imaging, Inc.	LNH	Class II	1992-09-22
K922525	Dall Miles Broad Bone Plate	Howmedica Corp.	HRS	Class II	1992-09-22
K922379	Sterile Latex Examination Gloves	Smith & Nephew Perry	LYY	Class I	1992-09-22
K922025	Anastomart(tm) Coronary Bypass Graft Markers/modif	Pioneering Technologies, Inc.	DSY	Class II	1992-09-22
K922020	Endomed 582	Henley Intl.	LIH	Class II	1992-09-22
K921828	Team-Mc II	Henley Intl.	GZJ	Class II	1992-09-22
K920549	Sharpe Endoneedle Holder	Paladin Medical, Inc.	HET	Class II	1992-09-22
K920548	Sharpe Endoscalpel	Paladin Medical, Inc.	HET	Class II	1992-09-22
K915468	Model P-81 Critikon Printer	Critkon, Inc.	DXN	Class II	1992-09-22
K923594	Clottrac Coagulation Control	Medtronic Hemotec, Inc.	JBP	Class II	1992-09-21
K923356	Medx Rotational Gantry System	Bfi- Medical Waste Systems	IYX	Class I	1992-09-21
K923130	Ir-192 Implant -- Modification	Omnitron Intl., Inc.	KXK	Class II	1992-09-21
K923098	Sterile Mucous Specimen Trap, Disposable	Trinity Laboratories, Inc.	BSY	Class I	1992-09-21
K922549	Ust-665P-5, Ust-664-5/7.5, Asu-35Wl-10, Scu-35	Aloka Co., Ltd.	ITX	Class II	1992-09-21
K922503	Howmedica(r) Hnr System	Howmedica Corp.	JDI	Class II	1992-09-21
K922462	Nextec Fiberoptic Cables	Nextec Corp.	HBI	Class II	1992-09-21
K922266	Alta Femoral Intramedullary Rod System, Add Sizes	Howmedica Corp.	HSB	Class II	1992-09-21
K921833	Endopath Endo-Surgery Percutaneous Catheter Introd	Ethicon, Inc	FMF	Class II	1992-09-21
K921702	Meri-Dapt(tm) Hemostasis Valve/torqloc Torque Devi	Merit Medical Systems, Inc.	DQX	Class II	1992-09-21
K921576	Strato Lifeport Large Bore Infusion Set	Starto Medical Corp.	FPA	Class II	1992-09-21
K920797	Hemodialysis Blood Tubing Set	National Medical Care, Medical Products Div., Inc.	FJK	Class II	1992-09-21
K920697	Dextrolyte II Peritoneal Dialysis 48-3029-7 Clamp	National Medical Care, Medical Products Div., Inc.	FJH	Class II	1992-09-21
K920693	Dextrolyte II Peritoneal Dialysis 48-3028-9	National Medical Care, Medical Products Div., Inc.	FJG	Class II	1992-09-21
K920586	Dextrolyte II Peritoneal Dialysis Admin. Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1992-09-21
K920526	Stryker Dynamic Mattress System (Dms) Model #2500	Stryker Medical	IOG	Class I	1992-09-21
K920029	Dextrolyte II Capd Trnsfer Set	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1992-09-21
K915726	Pulmonary Artery Flow-Directed Thermodilution Cath	Baxter Healthcare Corporation	DQO	Class II	1992-09-21