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 2026-11-02, 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 2490 of 3531

510(k) clearances, page 2490 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K904523	Antimicrobial Susceptibility Test Panel/modified	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1990-12-21
K904379	Surgical Trocar and Cannula	Applied Vascular Devices, Inc.	HET	Class II	1990-12-21
K904196	Micro-Mist Nebulizer	Bp, Ltd.	CAF	Class II	1990-12-21
K903958	Serofast	Intl. Mycoplasma/Mdc Assoc.	GSA	Class I	1990-12-21
K903925	Aries Meldical Model 2100Hc Hank Crank	Aries Medical, Inc.	KFM	Class II	1990-12-21
K903575	Chiroflex Forceps	Chiron Ophthalmics	KYB	Class I	1990-12-21
K903559	High Risk	Medical Resources, Ltd.	LYY	Class I	1990-12-21
K903209	Maxi-Flow Insufflator Tubing Set W/filter	Adler Instrument Company	HES	Class II	1990-12-21
K903145	Hearset Telephone Hearing System	Starkey Laboratories, Inc.	ESD	Class I	1990-12-21
K903132	Ortho Chlamydia Antigen Elisa/elisa Cult Extra Buf	Ortho Diagnostic Systems, Inc.	LJC	Class I	1990-12-21
K902907	Mamba Condom (Rubber Latex)	Rfsu	HIS	Class II	1990-12-21
K902306	The Visonic Dome(tm)	Vista Vision	LYL	Class II	1990-12-21
K902178	Yuefa Disposable Syringe	Blue & Red Corp.	FMF	Class II	1990-12-21
K901597	Indx Dip S Ticks	Intercare Diagnostics, Inc.	LSQ	Class I	1990-12-21
K900924	Wilson-Cook Balloon Dilation Catheters	Wilson-Cook Medical Inc.	KNQ	Class II	1990-12-21
K896734	Feeding Tube	Unoplast A/S	FPD	Class II	1990-12-21
K905510	Lifepak 9 Defibrillator & Cardiac Monitor/modified	Physio Control, Inc.	LDD	Class II	1990-12-20
K905101	Neonatal/sterile/dispos/noninvas Blood Press Cuff	Hewlett-Packard Co.	DXQ	Class II	1990-12-20
K905085	Raichem Ggt Reagent	Reagents Applications, Inc.	JQB	Class I	1990-12-20
K905084	Raichem Creatine Kinase Reagent, Optimized UV	Reagents Applications, Inc.	CGS	Class II	1990-12-20
K905016	Pediatric and Infant Cath Kits	Davol, Inc.	FFH	Class II	1990-12-20
K904892	Vacuum Bake Cycle	Medtronic, Inc.	DXY	Class III	1990-12-20
K904465	Flexible Arthroscope	Intramed Laboratories, Inc.	HRX	Class II	1990-12-20
K904383	Acufit Total Hip	Acu Med, Inc.	KWY	Class II	1990-12-20
K904376	Aneroid Blood Pressure Gauge	Biomedical Dynamics, Inc.	FCY	Class I	1990-12-20
K904353	Cardiomatic Model Msc-2001	Medical Systems Corp.	DRT	Class II	1990-12-20
K903993	Microzyme(tm) Methamphet/amphet Enzyme Immuno Kit	IMMUNOTECH s.r.o.	DKZ	Class II	1990-12-20
K903621	Magnum-20 (Tm) Inflation Device	Vascumed Systems	MAV	Class II	1990-12-20
K903365	Ketorex Sanwa Standards	Ihara Medics U.S., Inc.	JIN	Class I	1990-12-20
K902650	Bodyheat	Medadvances, Inc.	DWJ	Class II	1990-12-20
K896047	The Omnifit Epf Hip Joint Femoral Stem	Osteonics Corp.	MEH	Class II	1990-12-20
K905550	Patient Examination Gloves	Medical Device Inspection Company	LYY	Class I	1990-12-19
K905515	Zoetic Gloves	Janco Polymers Pvt., Ltd.	LYY	Class I	1990-12-19
K905478	Yankauer Suction Device	Medovations, Inc.	MDM	Class I	1990-12-19
K905187	Bone Rasps	Micro Surgical Instruments Corp.	HSZ	Class I	1990-12-19
K905126	Comfort-Aire	Advanced Air Dynamics, Inc.	IOQ	Class II	1990-12-19
K905046	Dermabrader	Apyx Medical Corporation	GFE	Class I	1990-12-19
K905013	T.c.s. Total Contact Seat	Fundamental Products Co.	KNN	Class I	1990-12-19
K904614	Gdc-1475	Deringer-Ney, Inc.	EJT	Class II	1990-12-19
K904610	Hercules Model 5000 and 5040 Nd:yag Laser Systems	Heraeus Lasersonics, Inc.	GEX	Class II	1990-12-19
K904354	Lpi Mulilase Yag/532 Surgical Laser System	Laser Photonics, Inc.	GEX	Class II	1990-12-19
K904342	Series 1990 Argon Surgical Lasers, E1,e6,e14&e20a	Hgm Medical Laser Systems, Inc.	GEX	Class II	1990-12-19
K904198	Safety Needle Sheath	Concord/Portex	FMI	Class II	1990-12-19
K903992	Cygnet Central	Cygnet Co., Inc.	HGM	Class II	1990-12-19
K903761	Curity Spinal Anesthesia Tray	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1990-12-19
K902988	G.e. Msi 850/850Ii/1250 Three Phase Generators	Electromek Diagnostic Systems, Inc.	IZO	Class I	1990-12-19
K902985	G.e. Mst 625/625Ii/mst 1050/1050Ii Three Phase Gen	Electromek Diagnostic Systems, Inc.	IZO	Class I	1990-12-19
K902822	Medical Designs, Inc., Spectrum II TENS Device	Medical Design & Manufacturing Corp.	GZJ	Class II	1990-12-19
K902754	Anesthetic Gas Calibration Mixture	Liquid Air Corp.	BXK	Class I	1990-12-19
K896098	Guardian & Janitex Condom/prophylactic	Allied Rubber Industries Sdn. Bhd.	HIS	Class II	1990-12-19