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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3523 of 3526

510(k) clearances, page 3523 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760275	Treadmill (Tms-300)	Burdick Corp.	IOL	Class I	1976-08-11
K760256	Test System, Ria Cortisol	Corning Medical & Scientific	CGR	Class II	1976-08-11
K760242	Probecot II	Measurement-Science Corp.			1976-08-11
K760237	Gown, Boundary Single Use Reinforced	Procter & Gamble Mfg. Co.	FYA	Class II	1976-08-11
K760212	Drapes, Barrier, Sterile Patient Ready	Surgikos, Inc.	KKX	Class II	1976-08-11
K760210	Blanket, Water-Jel Fire	American Safety	FPY	Class I	1976-08-11
K760034	Test, Strep, Latex Slide	Gamma Biologicals, Inc.	DEM	Class II	1976-08-11
K760311	Instruments, General Hand & Surgery	Depuy, Inc.	FSM	Class I	1976-08-09
K760309	Limb Holder, Tecnol Reminder	Tecnol New Jersey Wound Care, Inc.			1976-08-09
K760257	Sponge, Richards Wound Drainage System	Richard'S Medical Equip., Inc.	GCY	Class I	1976-08-09
K760248	Gloves, Aparticulate Surgical	Deknatel, Inc.	KGO	Class I	1976-08-09
K760213	Lenses, Contact, Polymethyl Methacrylate	Progressive Affiliated Labs, Inc.	HPX	Unclassified	1976-08-09
K760168	Pencil, Electrosurgical	Dytek Corp.	GEI	Class II	1976-08-09
K760022	Needle, Filter	Jelco Laboratories	GAA	Class I	1976-08-09
K760230	Valve, PEEP	Ohio Medical Products	BYE	Class II	1976-08-06
K760228	Anesthesia Machine, Chemetron	Chemetron Health Systems	BSZ	Class II	1976-08-06
K760222	Filter, Transfusion Blood, Intersept	Surgikos, Inc.	CAK	Class II	1976-08-06
K760167	Bag, Post Operative Lung Exercizing Blow	Dytek Corp.	BWF	Class II	1976-08-06
K760165	Filter, Infusion Blood (1 Pff-100)	Bentley Laboratories, Inc.	CAK	Class II	1976-08-06
K760088	Analyzer, Sentorr Blood Gas	Ohio Medical Products	CCC	Class II	1976-08-06
K760330	Cannula, Disposable Oxygen Ttherapy	Inhal-O-Tech Medical Plastic	CAT	Class I	1976-08-04
K760326	Surgical Instruments, Opthalmic	Depuy, Inc.	HNF	Class I	1976-08-04
K760317	Regulators, High Suction	Harris-Lake, Inc.	KDP	Class II	1976-08-04
K760316	Regulators, Low Suction	Harris-Lake, Inc.	KDP	Class II	1976-08-04
K760314	Flowmeter, Oxygen	Harris-Lake, Inc.	CAX	Class I	1976-08-04
K760313	Kit, Prep, Inspiron IV	Inspiron Corp.	KZD	Class I	1976-08-04
K760312	Electrode, Pns	Ndm Corp.	GXY	Class II	1976-08-04
K760263	I.p.p.b. Manifold/nebulizer (Circuit)	Foregger	CBO	Class II	1976-08-04
K760249	Tray, Sterile Disposable Arthrogram	Travenol Laboratories, S.A.	CAZ	Class II	1976-08-04
K760246	Endotracheal T Connector	Sherwood Medical Industries	BXA	Class I	1976-08-04
K760204	Buttons, Pmma (for Contact Lenses)	Burton Parsons & Co., Inc.	HPX	Unclassified	1976-08-04
K760199	Electroretinograph	LKC Technologies, Inc.	HLZ	Class II	1976-08-04
K760191	Knife, Troutman Corneal Large	V. Mueller O.V. Baxter Healthcare Corp.	HNN	Class I	1976-08-04
K760190	Scissors, Iris Straight	V. Mueller O.V. Baxter Healthcare Corp.	HNF	Class I	1976-08-04
K760188	Scissors, Micro Iris Curved	V. Mueller O.V. Baxter Healthcare Corp.	HNF	Class I	1976-08-04
K760187	Knife, Troutman Corneal Small	V. Mueller O.V. Baxter Healthcare Corp.	HNN	Class I	1976-08-04
K760186	Dissector, Troutman Corneal	V. Mueller O.V. Baxter Healthcare Corp.	HNN	Class I	1976-08-04
K760185	Scissors, Micro Iris Straight	V. Mueller O.V. Baxter Healthcare Corp.	HNF	Class I	1976-08-04
K760162	Hematology Control	Biological Corp. of America	JPK	Class II	1976-08-04
K760325	Surgical Instruments, Orthopedic	Depuy, Inc.	HTX	Class I	1976-08-03
K760324	Bonding Agent, Prestige	Lee Pharmaceuticals	KLE	Class II	1976-08-03
K760323	X-Ray Unit, Dental Diagnostic	The S. S. White Co.	EAP	Class II	1976-08-03
K760322	Chair, Attached Instrument Del. Sys.	The S. S. White Co.	KLC	Class I	1976-08-03
K760321	Chair, Dental Operative	The S. S. White Co.			1976-08-03
K760318	Actin, Activated Cephaloplastin Reagent	Dade, Baxter Travenol Diagnostics, Inc.	GFO	Class II	1976-08-03
K760262	Radioassy Kit, 3H-Folate	Diamond Shamrock Corp.	CGN	Class II	1976-08-03
K760243	Gloves, Sterile Latex Surgeon's	Travenol Laboratories, S.A.	KGO	Class I	1976-08-03
K760221	I.p.p.b., Dis. W/manifold/nebulizer	Manner Medical Products	CBO	Class II	1976-08-03
K760220	Tubing, Single Use Oxygen Supply	Manner Medical Products	BYX	Class I	1976-08-03
K760219	Maska, Oxygen Vinyl D-Sp. Single Use	Manner Medical Products	BYG	Class I	1976-08-03