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 1798 of 3531

510(k) clearances, page 1798 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982613	Omni Pro Latex Surgical Glove, Powdered	Omnigrace (Thailand), Ltd.	KGO	Class I	1998-09-02
K982578	Quanti-Test System	Panatrex, Inc.	SCL	Class II	1998-09-02
K982157	Trex MRI Magnetic Resonance Diagnostic Device	Field Effects	LNH	Class II	1998-09-02
K982060	Volumax CT Imaging System	Elscint, Inc.	JAK	Class II	1998-09-02
K982050	Model Ms-2 Handpiece	Parkell, Inc.	EFB	Class I	1998-09-02
K982045	Nucamma Rx	Is2 Research, Inc.	KPS	Class II	1998-09-02
K982044	Nucamma R+	Is2 Research, Inc.	KPS	Class II	1998-09-02
K982005	Wallstent Transhepatic Biliary Endoprosthesis	Boston Scientific Corporation	FGE	Class II	1998-09-02
K982002	Accu-Chek Comfort Curve Test Strip	Boehringer Mannheim Corp.	LFR	Class II	1998-09-02
K981970	Algetral, Cavex Chromatic, Ca 37 Superior Pink, Ca 37 Fast Set, Cavex Rainbow, Cavex Impressional Normal Setting, Cavexi	Cavex Holland B.V.	ELW	Class II	1998-09-02
K981032	Piv System	Medical Solutions, Inc.	LDQ		1998-09-02
K980686	Aesculap Hilan Motor System	Aesculap Inc	HBB	Class II	1998-09-02
K974770	Acqplan	Philips North America LLC	MUJ	Class II	1998-09-02
K974062	Medsci 3% Glutaraldehyde	Medsci, Inc.	MED	Class II	1998-09-02
K982904	Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact Lens	Les Laboratoires Blanchard	LPL	Class II	1998-09-01
K982501	Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent A443-330, CO2 Alkaline Buffer A44	Alko Diagnostic Corp.	JIX	Class II	1998-09-01
K982345	Vasco Scanning Beam Digital X-Ray System	Cardiac Mariners, Inc.	JAA	Class II	1998-09-01
K982193	Esophageal Stethoscope	Shore Medical, Inc.	BZT	Class II	1998-09-01
K981952	Combination Nd:yag and Frequency Doubled Solid State Green Laser	Instruments for Medicine and Diagnostics	GEX	Class II	1998-09-01
K981168	Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops	Allergan	LPN	Class II	1998-09-01
K980762	Pall Stat-Prime D Blood Filter for Extracorporeal Service	Pall Corp.	DTM	Class II	1998-09-01
K980721	Sullivan Autoset	ResMed Corp	BZD	Class II	1998-09-01
K982900	Phantom Softhread Soft Tissue Interference Screw	Depuy, Inc.	MAI	Class II	1998-08-31
K982677	Uni/monopolar HF Cable	Richard Wolf Medical Instruments Corp.	GEI	Class II	1998-08-31
K982607	Manual Wheelchair	G. Hirsch and Co., Inc.	IOR	Class I	1998-08-31
K982347	Depuy Ace Timax Pilon Plate	Depuy Ace Medical Co.	HRS	Class II	1998-08-31
K982248	Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-a	Howmedica Corp.	LPH	Class II	1998-08-31
K982158	Scout	Burke, Inc.	ITI	Class II	1998-08-31
K982155	Short Straight-in Bone Screw Fixation System	Influence, Inc.	MBI	Class II	1998-08-31
K982141	Arrow 5Fx60cm Balloon Embolectomy Catheter, Model # Em-56025	Arrow Intl., Inc.	DXE	Class II	1998-08-31
K982068	Howmedica Titanium Hoffmann Fixation Pin System	Howmedica Corp.	JDW	Class II	1998-08-31
K982066	Mp-3 Power Base Chair	Merits Health Products, Inc.	ITI	Class II	1998-08-31
K981934	The Bagnoli-4 EMG System	Delsys Inc.	HCC	Class II	1998-08-31
K981066	Fukuda Denshi: Cardiomax, Model Fx-4010 Multi Channel Electrocardiograph	Fukuda Denshi USA, Inc.	LOS		1998-08-31
K980489	Vapamasta 6	Medical Industrial Equipment	CAD	Class II	1998-08-31
K973649	Hemosite Test System	Gds Technology, LLC	KHG	Class II	1998-08-31
K964977	Ivoc- Integrated Voice Operated Control Unit (Ivoc-1)	Interactive Living Systems, Inc.	LFF	Class I	1998-08-31
K982908	Modification to Ebi Spinelink System	Electro-Biology, Inc.	KWP	Class II	1998-08-28
K982740	Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S 301-803A, 301-803P, 301-803M, 301-813S	Cordis Webster, Inc.	DYB	Class II	1998-08-28
K982079	Accu-Check Voicemate	Boehringer Mannheim Corp.	LFR	Class II	1998-08-28
K981916	Ligasure Vessel Sealing System	Medtronic, Inc.	GEI	Class II	1998-08-28
K981653	Amy	Abbott Medical	JFJ	Class II	1998-08-28
K981180	Rejoyn Constriction Ring Kit, Pos-T-Vac B-100 Ring Kit, Pos-T-Vac B-25 Ring Kit and Pos-T-Vac B-10 Ring Kit	Pos-T-Vac, LLC	LKY	Class II	1998-08-28
K981011	Pos-T-Vac (Rejoyn Vacuum Erection Device)	Pos-T-Vac, LLC	LKY	Class II	1998-08-28
K982594	Endo-Scrub/endo-Scrub 2	Xomed, Inc.	EOB	Class II	1998-08-27
K982366	Quanta Lite Ttg (Tissue Transglutaminase) Elisa	Inova Diagnostics, Inc.	MVM	Class II	1998-08-27
K981705	'Rapid Drug Screen' 8 Panel-Low Volume	American Bio Medica Corp.	DKZ	Class II	1998-08-27
K981696	Il Test Plasmin Inhibitor	Instrumentation Laboratory Co.	GGP	Class II	1998-08-27
K981041	Slt Bipolar Sheath	Surgical Laser Technologies, Inc.	ERL	Class II	1998-08-27
K980831	Image Post-Processing Techniques	Philips North America LLC	LNH	Class II	1998-08-27