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 2380 of 3531

510(k) clearances, page 2380 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915280	Femostop	Radi Medical Systems AB	DXC	Class II	1992-04-22
K914445	Perry(r) Natural Powder-Free Gloves, Style 45	Smith & Nephew Perry	KGO	Class I	1992-04-22
K914028	Rubella Igm Elisa Test System	Zeus Scientific LLC	LFX	Class II	1992-04-22
K913426	Albicans Sure	Jrga Diagnostics	JXC	Class I	1992-04-22
K913380	Mydas(tm)-Mb2/mydas(tm)-Mb	Intl. Immunoassay Laboratories, Inc.	JHX	Class II	1992-04-22
K912577	Bacteria Filter	Vital Signs, Inc.	CAH	Class II	1992-04-22
K921385	Improved Sequence Light Cure Adhesive	Ormco Corp.	DYH	Class II	1992-04-21
K920816	Percuguide Lesion Marking	E-Z-EM, Inc	GDF	Class I	1992-04-21
K920781	Flash Bond	Advanced Orthodontics Systems, Inc.	DYH	Class II	1992-04-21
K920768	Hollow Screw Implants 6Mm, 14Mm, 16Mm	Straumann USA, LLC	DZE	Class II	1992-04-21
K920692	Septocalcine Ultra	Specialites Septodont	EJK	Class II	1992-04-21
K920677	Clearsite Hydrogel Wound Dressing Modification	New Dimensions in Medicine, Inc.	NAE	Class I	1992-04-21
K920613	Dw 215-12A Alloy for Forcelain Fused to Metal	Ivoclar North America, Inc.	EJS	Class II	1992-04-21
K920344	Sunglasses	J & D Products, Inc.	HQY	Class I	1992-04-21
K920293	Davis and Geck Handheld Inst. Sterilization Tray	Davis & Geck, Inc.	FLE	Class II	1992-04-21
K920286	Depuy Total Hip Balls - Ion Implantation	Depuy, Inc.	JDI	Class II	1992-04-21
K920271	Weinstein Corneal Mircoaesthesiometer	Connecticut Bioinstruments, Inc.	HJC	Class I	1992-04-21
K915668	Bisco Cavity Cleanser	Bisco, Inc.	EBF	Class II	1992-04-21
K915250	Wil-Pds & Wil-Pdi Casting Alloys	Wilde-USA, Inc.	EJH	Class II	1992-04-21
K915182	Deroyal Hydrogel Dressing	DeRoyal Industries, Inc.	NAE	Class I	1992-04-21
K915165	Argebond 77+	Argen Precious Metals, Inc.	EJS	Class II	1992-04-21
K914759	Bloom Transparent Stencil	Freckles Publications, Inc.	FZZ	Class I	1992-04-21
K914382	Life-Air 1000 Hypothermic Treatment System	Progressive Dynamics, Inc.	DWJ	Class II	1992-04-21
K913882	Zara Silicone Block	Byron Medical	MIB	Class II	1992-04-21
K913089	Wilde Light Curing Composite Restorative Resins	Wilde-USA, Inc.	EBF	Class II	1992-04-21
K910422	Model Rd-1200 Ruby Laser System	Spectrum Medical Technologies, Inc.	GEX	Class II	1992-04-21
K905536	Fetal Doppler	Toshiba America Medical Systems, In.C	MAA	Class II	1992-04-21
K921528	Hill-Rom Patient Environmental Control System	Hill-Rom Inc.	IQA	Class II	1992-04-20
K920720	Digital Radiography System Idr-1000	Shimadzu Medical Systems	JAA	Class II	1992-04-20
K920444	Ultimate	Jobst Institute, Inc.	DWL	Class II	1992-04-20
K920321	Becton Dickinson Safety-Lok Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1992-04-20
K920250	Osteonics Microsurfaced Cdh Hip Stem	Stryker Corp.	JDI	Class II	1992-04-20
K920104	Identi Loops Degania Silicone	Puritas Health Care, Inc.	DSS	Class II	1992-04-20
K915775	Millar Nonmagnectic Mikro-Tip Catheter Press. Tran	Millar LLC.	DXO	Class II	1992-04-20
K914786	Target Therapeutics Coils	Target Therapeutics	KRD	Class II	1992-04-20
K914309	The Genesis Bed from Hill-Rom, Model 355 Series	Hill-Rom Inc.	HDD	Class II	1992-04-20
K912742	Esophageal Stethoscope Temperature Probe	Spacelabs, Inc.	FLL	Class II	1992-04-20
K910555	Tutoplast Dura	Pfrimmer-Viggo GmbH & Co.	LEM	Class II	1992-04-20
K903440	Vivamed Fistula Needle	S.S. Ent.	FIE	Class II	1992-04-20
K921141	Cannabinoid Urine Controls	Diagnostic Reagents, Inc.	LAS	Class I	1992-04-17
K920981	Ristocetin Cofactor Assay/von Willebrand Fact Assa	Medical Diagnostic Technologies, Inc.	GGP	Class II	1992-04-17
K920962	Multiple Accessory to Gamma Cameras	Nu Age Products	IYZ	Class I	1992-04-17
K920940	Amerlite Free Thyroid Control Sera Lan.4002	Eastman Kodak Company	JJY	Class I	1992-04-17
K920933	Bactec Fos Culture Supplement	BD Becton Dickinson Vacutainer Systems Preanalytic	MDB	Class I	1992-04-17
K920809	King Diagnostics Sodium/potassium Standard	King Diagnostics, Inc.	JIS	Class II	1992-04-17
K920766	T4 Eia Bead Assay	Tech-Co, Inc.	CDX	Class II	1992-04-17
K920314	Txit D.a.u. Barbiturate Assay (Modification)	Syntex Corp.	DIS	Class II	1992-04-17
K915498	Cordis Angiographic Doppler Cather	Cordis US Corp.	DQO	Class II	1992-04-17
K910966	Sector Transducer Model No. Awp3.5/a	Kretztechnik AG	ITX	Class II	1992-04-17
K920750	Bard Ureteroscope Deflection Module	C.R. Bard Inc	FGB	Class II	1992-04-16