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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2988 of 3529

510(k) clearances, page 2988 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850270	Corneal Light Shield	Mentor O & O, Inc.	HRM	Class I	1985-05-31
K843815	Evomatic 8000/4000	Dantec Electronics, Inc.	GWF	Class II	1985-05-31
K852140	Namic Contrast & Fluid Delivery Spikes(various)	North American Instrument Corp.	FPA	Class II	1985-05-30
K852030	Pediatric IV Watch	Alltek, Inc.	FPB	Class II	1985-05-30
K852029	i.v. Watch	Alltek, Inc.	FPB	Class II	1985-05-30
K852010	Tgl Reagent	Alpkem Corp.	CDT	Class I	1985-05-30
K852009	T-Cho Reagent	Alpkem Corp.	CHH	Class I	1985-05-30
K852008	T-Bil Reagent, D-Bil Reagent, Sodium Nitrite & Sul	Alpkem Corp.	CIG	Class II	1985-05-30
K852007	Alb Bcg Reagent	Alpkem Corp.	CIX	Class II	1985-05-30
K852000	Ck-Nac Reagent	Alpkem Corp.	CGS	Class II	1985-05-30
K851998	Alp(alkaline)(phosphatase) Reagent	Alpkem Corp.	CJE	Class II	1985-05-30
K851997	Ld-P Reagent	Alpkem Corp.	CFJ	Class II	1985-05-30
K851995	Alt (Alanine Amino-Thransferase)reagent	Alpkem Corp.	CKA	Class I	1985-05-30
K851993	Cre Buffer Cre Dye	Alpkem Corp.	CGX	Class II	1985-05-30
K851887	On Target	Newman Assoc.	HPX	Unclassified	1985-05-30
K851792	37-940 to 37-944 Various Noyes Ophthalmic Forceps	Artiberia	HNR	Class I	1985-05-30
K851791	37-610 to 37-880 Various Ophthal-Forceps	Artiberia	HNR	Class I	1985-05-30
K851661	Solex & Saxon Int'l Optical of Hong Kong	South West Intl., Inc.	HQZ	Class I	1985-05-30
K851564	Model 2000 Indulin Infusion Pump	BD Becton Dickinson Vacutainer Systems Preanalytic	FRN	Class II	1985-05-30
K851557	Anesthesiometer	Luneau SA	HJC	Class I	1985-05-30
K851351	Enteral Feeding Pump	Empire Industries, Inc.	FRN	Class II	1985-05-30
K851336	Iv/0165 Infusion Set	Infarkem Corp.	FPA	Class II	1985-05-30
K851163	Sunglases	Full See Glasses Ind. Co., Ltd.	HQG	Class I	1985-05-30
K851130	Spectacle Frame	New Brillette A/S	HQZ	Class I	1985-05-30
K850069	Borning Neonatal Resuscitatoin Center	Borning Corp.	FMT	Class II	1985-05-30
K852035	Health-O-Meter Physicians, Digital Elec Scales	Continental Scale Corp.	FRW	Class I	1985-05-29
K852027	Ggtp Reagent/serum Iron/salicylate Demand Analyzer	Advanced Biomedical Methods, Inc.	DKJ	Class II	1985-05-29
K852004	Ua(uricase) Reagent	Alpkem Corp.	KNK	Class I	1985-05-29
K851992	Glu(god) Reagent	Alpkem Corp.	CGA	Class II	1985-05-29
K851991	Un(urease)reagent Un(a-Keto)reagent	Alpkem Corp.	KNK	Class I	1985-05-29
K851841	Imax Periotips	Stram Dental, Inc.			1985-05-29
K851746	1-110 Otoscope Set Battery Powered Diag. Set 3Pcs.	Artiberia	ERA	Class I	1985-05-29
K851673	Raka Och Bosda Peanger	General Electric Trading Co.	GEN	Class I	1985-05-29
K851569	Vera Bond Non Percious Ceramic Alloy	Aalba Dent, Inc.	EJH	Class II	1985-05-29
K851547	Behind the Ear Hearing Aid Model Bernafon T-82	Bernafon LLC	ESD	Class I	1985-05-29
K851430	Earette Hearing Aid(behind the Ear Oticon E37f	Oticon, Inc.	ESD	Class I	1985-05-29
K851429	Earette Hearing Aid(behind the Ear Oticon E35f	Oticon, Inc.	ESD	Class I	1985-05-29
K851390	Sterile General Hospital Supplies	Biological & Environmental Control Laboratories	LDQ		1985-05-29
K851388	Septosil Silicone for Precision Impression	Specialites Septodont	ELW	Class II	1985-05-29
K851349	Lere Nail & Plate Combin. One Piece Forged	Medicalex	KTW	Class II	1985-05-29
K851238	Chamber V-9 Plus Agar	Bug City Company, Inc.	JSJ	Class I	1985-05-29
K851127	Dupont Aca Prothrombin Time/activated Partial Thro	E.I. Dupont de Nemours & Co., Inc.	JPA	Class II	1985-05-29
K851126	Aca Activated Partial Thromboplastin Time Analytic	E.I. Dupont de Nemours & Co., Inc.	GGW	Class II	1985-05-29
K851125	Aca Prothrombin Time Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	GJS	Class II	1985-05-29
K850918	Type Fp30 Digital Hearing Aid Analyzer	Frye Electronics, Inc.	ETW	Class II	1985-05-29
K850772	Bactigen Group B Streptococcus Test	Armkel, LLC	GTZ	Class I	1985-05-29
K850769	Viggo Accessories for i.v. Therapy	Viggo Products	FPA	Class II	1985-05-29
K850666	Strobex Ultron Electrosurge-Dental Unit	Ipco Corp.	EKZ	Class II	1985-05-29
K850566	Marukyr-Ban / Hot or Heat Pack	Oriental Medical Supplies, Inc.	IMD	Class I	1985-05-29
K850039	Halifax Spinal Clamp	Levtech, Inc.	KWP	Class II	1985-05-29