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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3322 of 3528

510(k) clearances, page 3322 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802688	Rheumatoid Factor Test Systems	BD Becton Dickinson Vacutainer Systems Preanalytic	DHR	Class II	1980-12-18
K802601	Endotracheal Tube Holder	Hudson Oxygen Therapy Sales Co.	CBH	Class I	1980-12-18
K802586	American Heyer-Schulte Low Profile Valve	American Heyer Schulte	JXG	Class II	1980-12-18
K802583	Infant Ventilator, (Respirator) Plan B	Healthdyne, Inc.	CBK	Class II	1980-12-18
K802578	Pace-4-Automatic Ria Gamma-Couter	Philips North America LLC	JJJ	Class I	1980-12-18
K802535	Hydroxylate Dental Composite Restroative	Wallace A. Erickson & Co.	EBF	Class II	1980-12-18
K802532	Pfizonic 300 Ultrasound Scanner	Pfizer Medical Systems, Inc.	IYO	Class II	1980-12-18
K802531	Pfizonic 200 Ultrasound Scanner	Pfizer Medical Systems, Inc.	IYO	Class II	1980-12-18
K802530	Pfizonic 250 Ultrasound Scanner	Pfizer Medical Systems, Inc.	IYO	Class II	1980-12-18
K802529	Pfizonic 100 Ultrasound Scanner	Pfizer Medical Systems, Inc.	DXK	Class II	1980-12-18
K802528	Pfizonic 150 Ultrasound Scanner	Pfizer Medical Systems, Inc.	IYO	Class II	1980-12-18
K802508	Rubelisa Igm Test Kit	M.A. Bioproducts	GOL	Class II	1980-12-18
K802495	Clostridium Difficile Agar Base	Oxoid U.S.A., Inc.	JSJ	Class I	1980-12-18
K802452	Toxotest-Mt Eiken Kit	Syn-Kit, Inc.	GMM	Class II	1980-12-18
K802441	Clirans Th10 Hollow Fiber Dialyzer	Terumo America, Inc.	FJI	Class II	1980-12-18
K802339	Eia Rubella-G	Beckman Instruments, Inc.	GOL	Class II	1980-12-18
K802122	Clirans Th13 Hollow Fiber Dialyzer	Terumo America, Inc.	FJI	Class II	1980-12-18
K802114	Nephross Dialyzer	bioMerieux, Inc.	FJI	Class II	1980-12-18
K802102	Rubella Elisa Reagents Rubella Igg Anti	Calbiochem-Behring Corp.	GOL	Class II	1980-12-18
K802092	HF-100 Dialyzer	Bio-Med Corp.	FJI	Class II	1980-12-18
K801748	3M I-125 Seeds in Absorbable Carrier	3M Company	KXK	Class II	1980-12-18
K801672	Medcomp Subclavian Catheter	Medical Components, Inc.	LFJ	Class II	1980-12-18
K801633	The Bravo New Parallel Flow Dialyzer	Bellco Artifidial Organ Spec., Inc.	FJG	Class II	1980-12-18
K801175	Silastic II Mammary Implant	Dow Corning Corp. Healthcare Industries Materials			1980-12-18
K803201	Lemon Glycerine Swabs	Walpak Co.			1980-12-17
K802954	Dressing Change Tray-Medium	Associated Medical Products Co.	FKO	Class II	1980-12-17
K802951	I.m Probes	Hogan & Hartson	HXB	Class I	1980-12-17
K802928	Spirometric Computer #Sc-10	Cavitron Corp.	BZC	Class II	1980-12-17
K802922	Porous Coated Anatomical-Total Knee	Howmedica Corp.	JWH	Class II	1980-12-17
K802911	A/k Socket	Orthomedics	ISS	Class I	1980-12-17
K802909	Humeral Fracture Brace	Orthomedics	IQI	Class I	1980-12-17
K802908	Ulnar Fracture Brace	Orthomedics	IQI	Class I	1980-12-17
K802901	Travenol Infusion Pump-2M8016	Travenol Laboratories, S.A.	FRN	Class II	1980-12-17
K802880	Extracorporeal's #Dm-952 Dialysate Bypas	Extracorporeal Medical Specialities, Inc.	FKP	Class II	1980-12-17
K802870	Rion Electro-Palatograph Model Dp-01	Kindel & Anderson	LEZ	Unclassified	1980-12-17
K802846	Tcm202 Tcpo2 & Tcm204 Tcpo2/po2 Rec. Sy.	The London Co.	KLK	Class II	1980-12-17
K802845	Concept Canaliculus Intubation Set	Concept, Inc.	HNL	Class I	1980-12-17
K802813	Pmr-2 Puritan Manual Resuscitator	Medtronic, Inc.	BTM	Class II	1980-12-17
K802799	Eye Pads	Secol Co.	HMP	Class I	1980-12-17
K802797	O.r. Drapes	Secol Co.	KKX	Class II	1980-12-17
K802791	Zinc Paste Bandage	Secol Co.	FRO	Unclassified	1980-12-17
K802787	Metalline Dressings	Secol Co.	KKX	Class II	1980-12-17
K802786	Poroplast-Eye Dressing	Secol Co.	HOY	Class I	1980-12-17
K802749	Blended Bifocal	Robinson-Houchin, Inc.	HQG	Class I	1980-12-17
K802679	Silanit	Vivadent (USA), Inc.	EBG	Class II	1980-12-17
K802651	Postoperative UV Glasses (Plano/aphakic)	Chiron Vision Corp.	HQG	Class I	1980-12-17
K802381	Lewicky Anterior Chamber Mainten. Sys.	Fibra Sonics, Inc.	HQC	Class II	1980-12-17
K802355	Metricon #120 Fluorophotometer	Metricon, Ltd.	HJO	Class II	1980-12-17
K802351	F110 Photo Binocular Ophthalmoscope	Minami, Tomine & Lew	HLG	Class I	1980-12-17
K802106	Lewis Trapezo Metacarpal Prosthesis	Howmedica Corp.			1980-12-17