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 1759 of 3531

510(k) clearances, page 1759 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K983171	Constellation Multiple Electrode Pacing and Recording System	Boston Scientific Corporation	MTD	Class II	1999-03-11
K982992	Zoll M Series Spo2 Option	ZOLL Medical Corporation	MKJ	Class III	1999-03-11
K982173	Buzbee	Mwr Electronics Industrial Co.	GZJ	Class II	1999-03-11
K990603	Modification of the Zplate-Atl Anterior Fixation System	Danek Medical, Inc.	KWQ	Class II	1999-03-10
K981996	Titanium Femoral Component	Zimmer GmbH	JWH	Class II	1999-03-10
K990578	Osom Card II Hcg-Urine Test, Model 102	Wyntek Diagnostics, Inc.	JHI	Class II	1999-03-09
K990576	Osom Card Pregnancy Test, Model 103	Wyntek Diagnostics, Inc.	LCX	Class II	1999-03-09
K990514	Modification of Bard Quantum Cvr, Model H-6770Vr	C.R. Bard Inc	DTP	Class II	1999-03-09
K990453	Nitrile Examination Gloves, Powder Free, Green Color	Alliance Rubber Products Sdn. Bhd.	LZA	Class I	1999-03-09
K990375	Disposable Monopolar Needle Electrode, Dmf 25; Dmn 25; Dmf 37; Dmn 37; Dmn 50; Dmn 75	Medtronic Functional Diagnostics A/S	IKT	Class II	1999-03-09
K990283	Blue Powder-Free Nitrile Examination Gloves	Hartalega Sdn Bhd	LZA	Class I	1999-03-09
K990282	Abbott Liquid Assayed Chemistry Control, Model 1E81-01/1E82-01	Bio-Rad	JJY	Class I	1999-03-09
K990108	Lc Flowfill	S & C Polymer GmbH	EBF	Class II	1999-03-09
K984608	Gentamicin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1999-03-09
K984581	System U3 for Cephalothin	Ab Biodisk	JWY	Class II	1999-03-09
K984491	System U3 for Cefuroxime	Ab Biodisk	JWY	Class II	1999-03-09
K984271	Modification of Maxima Forte' Hollow Fiber Oxygenator with Balance Biocompatible Surface with Plasma Resistent Fiber (M0	Medtronic, Inc.	DTZ	Class II	1999-03-09
K983379	Gti-Pf4 Elisa	Immucor GTI Diagnostics, Inc.	LCO	Class II	1999-03-09
K982283	Whisperflow Oxygen Flow Generator - Adjustable Model Wf 8500 Whisperflow Oxygen Flow Generator - Fixed Model Wf 8530 Wh	Caradyne, Ltd.	BYE	Class II	1999-03-09
K981446	Wako Autokit Lp(a)	FUJIFILM Healthcare Americas Corporation	DFC	Class II	1999-03-09
K990498	Optibond Solo Plus	Sybron Dental Specialties, Inc.	KLE	Class II	1999-03-08
K990035	RF	Abbott Medical	DHR	Class II	1999-03-08
K984394	Acs Hi-Torque Wiggle Guide Wire with Microglide Coating	Boston Scientific Corporation	DQX	Class II	1999-03-08
K983126	Fiberflo Hollow Fiber Capsule Water Filters	Medivators Inc	FIP	Class II	1999-03-08
K983105	Ccs; Computer Controlled Syringe, Model #Ccs-100, Ccs; Cartridge Holder (Replacements), Model # Ccs-100-01	Dentsply Midwest	EJI	Class II	1999-03-08
K990366	Exmoor Suction Clearance Kit	Exmoor Plastics Limited	LRC	Class I	1999-03-05
K990295	Bone Anchor System III (Bas III)	Boston Scientific Corporation	MBI	Class II	1999-03-05
K990156	Multitak Ss Buttons	Bonutti Research, Inc.	MBI	Class II	1999-03-05
K984623	Maxim Removable Molded Poly Tibia	Zimmer GmbH	JWH	Class II	1999-03-05
K984607	Panoview Plus Optic with 2.7Mm Diameter, Model 8672.Xxx, Panoview Plus Optic with 1.9Mm Diameter, Model 8686.Xxx	Richard Wolf Medical Instruments Corp.	FBP	Class II	1999-03-05
K984602	Syntec-Taichung Non-Sterile Unreamed Interlocking Nail System	Syntec Scientific Corp.	HSB	Class II	1999-03-05
K984552	Cool-Tip RF System	Radionics, Inc.	GEI	Class II	1999-03-05
K984443	Orbscan	Technolas Perfect Vision GmbH	MXK	Class II	1999-03-05
K984424	Aura Dye Laser System (Adls)	Laserscope	GEX	Class II	1999-03-05
K984382	Accu Guide	Tayman Medical, Inc.	IYO	Class II	1999-03-05
K983194	Sporicidin Sterilizing and Disinfecting Solution (Ssds)	Sporicidin Intl.	MED	Class II	1999-03-05
K983164	Restore (Aka Re/stor)	Nebl, Inc.	MNG	Class I	1999-03-05
K982952	Imfast	Siemens Medical Solutions USA, Inc.	LHN	Class II	1999-03-05
K981702	Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number Ws-300	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	1999-03-05
K980351	Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit	Boston Biomedica, Inc.	LSR	Class II	1999-03-05
K990379	Modification to Multaport Cannula, Reducer and Accessories	Dexide, Inc.	GCJ	Class II	1999-03-04
K990326	Optical Tracking System Microscope Module II, Model Ots Mmii	Radionics Software Applications, Inc.	HAW	Class II	1999-03-04
K990315	Monopaque	Ivoclar North America, Inc.	EBF	Class II	1999-03-04
K984596	Virastat Fitc-Labeled Anti-Influenza a and B Monoclonal Antibodies	Zymetx, Inc.	GNR	Class I	1999-03-04
K984502	Nerve Block Infusion Kit	Halyard Health	MEB	Class II	1999-03-04
K984357	Transfx External Fixation System	Immedica, Inc.	LXT	Class II	1999-03-04
K984352	Aaron Top50 Reusable Electrosurgical Pencil, Model #Espr	Apyx Medical Corporation	GEI	Class II	1999-03-04
K984017	Allison Medical Insulin Syringe (Amis)	Allison Medical, Inc.	FMF	Class II	1999-03-04
K983671	Natural Brand Acupuncture Needles	Tcm Supply Corp.	MQX	Class II	1999-03-04
K983071	Bilichek Non-Invasive Bilirubin Analyzer	Respironics, Inc.	MQM	Class I	1999-03-04