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 2268 of 3531

510(k) clearances, page 2268 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931911	Brillenerzeugung Pomberger or Multiple Spec Frames	Brillenerzeugung Pomberger	HQZ	Class I	1993-10-01
K931910	Brillenerzeugung Pomberger or Multiple Sunglasses	Brillenerzeugung Pomberger	HQY	Class I	1993-10-01
K931481	Mini-Lancet	Pacific Rim Products, Inc.	FMK	Class II	1993-10-01
K931431	Floater Sunglasses	Floater Eyewear, Inc.	HQY	Class I	1993-10-01
K931408	Sunglasses	Sunnycraft Philippines, Inc.	HQY	Class I	1993-10-01
K931350	Il Test Uric Acid	Instrumentation Laboratory Co.	KNK	Class I	1993-10-01
K931296	Paceart Cardiophone	Paceart, Inc.	DXH	Class II	1993-10-01
K931055	Item # 755 Hot Sunglasses	South American Industrial Co.	HQY	Class I	1993-10-01
K930807	Sentry Anterior Spinal System	Sofamor Danek Mfg., Inc.	KWQ	Class II	1993-10-01
K930710	Sentry Posterior Spinal System	Sofamor Danek Mfg., Inc.	KWP	Class II	1993-10-01
K925570	Sunglasses	De'Vons Products, Inc.	HQY	Class I	1993-10-01
K925187	Alibi Optical Frames and Sunglasses	Alibi Designs, Inc.	HQY	Class I	1993-10-01
K921909	Sterrad Bi Test Pack	Johnson & Johnson MEDICAL GmbH	FRC	Class II	1993-10-01
K915682	Sterrad 100 Sterilization System	Johnson & Johnson MEDICAL GmbH	FLF	Class II	1993-10-01
K915599	Cap Washer Assembly	Howmedica Corp.	KTT	Class II	1993-10-01
K933919	Microlite Wheelchair	Morgan Technology, Inc.	IOR	Class I	1993-09-30
K933577	Powermatic Examination Table	Medical Device Inspection Company	INQ	Class I	1993-09-30
K933406	Travel Ease	Merits Health Products, Inc.	IOR	Class I	1993-09-30
K933000	Reclining Geri Chairs W/casters & Lap Tray	Winco, Inc.	INM	Class I	1993-09-30
K932713	Trace Transferrin Reagent	Trace Scientific, Ltd.	DDQ	Class II	1993-09-30
K932625	Stair Assist(tm) Powered Grab Bar Transport	Stair Assist Corp.	ILK	Class II	1993-09-30
K932396	Peri-Comfort(tm) Seating Cushion	Chi'Am Intl.	LRL	Unclassified	1993-09-30
K931129	Techlab 1-Hour Tox-a-Test	Techlab, Inc.	LLH	Class I	1993-09-30
K931086	Windmere Vibra Touch Personal Body Massager	Windmere Corp.	IRO	Class I	1993-09-30
K931015	Devilbiss Model 4650 Compressor Neubulizer	Devilbiss Health Care, Inc.	BTI	Class II	1993-09-30
K930663	IV Comfort Pad	D.J. Scott Mfg., Inc.	KMK	Class I	1993-09-30
K926090	Syva Microtrak(r) II Chlamydia Eia Block Reagent	Syva Co.	LJC	Class I	1993-09-30
K925434	Sector & Transvaginal Model #'S Sw4/5b/a,ew5/7k/a	Kretz Technik	ITX	Class II	1993-09-30
K924520	Body Trainer	Conair LLC.	ISA	Class I	1993-09-30
K923947	Meadox Surgimed Balloon Catheter	Meadox Medicals, Div. Boston Scientific Corp.	LIT	Class II	1993-09-30
K933209	Visiontool	Evergreen Technologies, Inc.	LLZ	Class II	1993-09-29
K933206	Exa Bite Registration Material	GC America Inc.	ELW	Class II	1993-09-29
K933186	Dw 248 #46	Ivoclar North America, Inc.	EJT	Class II	1993-09-29
K933083	Dw247 #2	Ivoclar North America, Inc.	EJT	Class II	1993-09-29
K932990	Oral-B Disposable Prophy Angle W/prophy Cup	Oral-B Laboratories	EFB	Class I	1993-09-29
K932886	Alpha-Dent Light Activated Core Buildup Blue Paste	Wallace A. Erickson & Co.	EBF	Class II	1993-09-29
K932885	Auto Suture Endoscopic Instrument Clamp	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1993-09-29
K932785	Monoject(r) Monolettor Safety Lancet	Sherwood Medical Co.	FMK	Class II	1993-09-29
K931907	Anthos Ht Readers, Including the Anthos Ht Ii&iii	Anthos Labtec Instruments	JJQ	Class I	1993-09-29
K930602	Latex Examination Gloves, Powder Free	Tekmedic (M) Sdn Bhd	LYY	Class I	1993-09-29
K930553	Cub Dis Otoacoustic Emissions Test Instrument	Etymotic Research, Inc.	EWO	Class II	1993-09-29
K930544	Mrinnervu Disposable Endorectal Colon Coil,#pcc-15	Medrad, Inc.	LNH	Class II	1993-09-29
K930525	Micro Mist(tm) Nebulizer	Hudson Respiratory Care, Inc.	CAF	Class II	1993-09-29
K925647	Valleylab #E2751 & E2780r Laparoscopic Handpiece	Medtronic, Inc.	GEI	Class II	1993-09-29
K925094	Visualix Radiographic Image Detecting and Process	Gendex Corp.	EHD	Class II	1993-09-29
K923575	Coherent Versapluse 2.1 Holmium Surg. Lasers	Coherent Medical Group	GEX	Class II	1993-09-29
K922485	Chemdi-Vhp Chemical Indicator	American Sterilizer Co.	JOJ	Class II	1993-09-29
K920077	Nikkiso Nk Pump	International Medical Products, Inc.	DWD	Class II	1993-09-29
K933058	Hearttrack Quantitative Coronary Angiography Softw	Heartware Intl. Corp.	IZI	Class II	1993-09-28
K933019	Usci Super 6 6F Ptca Guiding Catheter	C.R. Bard Inc	DQY	Class II	1993-09-28