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 1736 of 3531

510(k) clearances, page 1736 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K992217	At Home Drug Test, Model 9175	Phamatech Inc.	MVO	Unclassified	1999-07-13
K992163	Abca Gas Isotope Ratio Mass Spectrometer Systems	Pdz-Europa, Ltd.	DOP	Class I	1999-07-13
K991992	Ultrafree Thick Sterile Latex Powder-Free Surgical Gloves	Medtronic, Inc.	KGO	Class I	1999-07-13
K991733	Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C Controls	Schiapparelli Biosystems, Inc.	MRR	Class I	1999-07-13
K991560	Naso-Laryngo-Pharyngoscope	Fiber Imaging Technologies, Inc.	EOB	Class II	1999-07-13
K991072	Ahmed Glaucoma Valve Implant	New World Medical, Inc.	KYF	Class II	1999-07-13
K990872	Scleral Plugs, 19 and 20 Gauge	Ophthalmic Consultants, Inc.	LXP	Class II	1999-07-13
K972772	Esp Culture System II - Myco Susceptibility Testing	Trek Diagnostic Systems, Ltd.	MJA	Class II	1999-07-13
K992230	Omnitip Side Firing Switchable Tip with Suction/irrigation, Model 20371-Hp	Trimedyne, Inc.	GEX	Class II	1999-07-12
K992208	Ge Logiq 200 Md Diagnostic Ultrasound System	GE Healthcare	IYO	Class II	1999-07-12
K992191	Eti-Ea-G Assay	Diasorin Inc.	LSE	Class I	1999-07-12
K992084	Cynosure Surescan with the Co3 Er: Yag Laser	Cynosure, LLC	GEX	Class II	1999-07-12
K992083	Scatterfree Lateral Emitting Fiber	Laser Peripherals LLC	GEX	Class II	1999-07-12
K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head	Depuy Orthopaedics Inc.	KWS	Class II	1999-07-12
K992031	Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)	Shanghai Changzheng Latex Factory	LYY	Class I	1999-07-12
K991940	Brightway Brand Nitrile Surgical Gloves - Sterile (Powdered)	Brightway Holdings Sdn. Bhd.	KGO	Class I	1999-07-12
K991917	Osteomark Ntx Point of Care (Poc) Control Set	Metrika, Inc.	JJW	Class I	1999-07-12
K991900	Xltek Polysomnography Headbox, Model # Psg-40	Excel Tech., Ltd.	OLV	Class II	1999-07-12
K991650	Cmv Brite Turbo Kit	Biotest Diagnostics Corp.	LIN	Class II	1999-07-12
K991485	Synergy Porous Size 8 Hip Stem	Smith & Nephew, Inc.	LPH	Class II	1999-07-12
K991400	Parietene Polypropylene Mesh	Sofradim Production	FTL	Class II	1999-07-12
K991377	Omnisonics Flexible Fiber Optic Endoscope and Coupler	Omnisonics Medical Technologies	GCJ	Class II	1999-07-12
K991336	Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy	Medical Instrumentation & Diagnostics Corp.(Midco)	IYE	Class II	1999-07-12
K991303	Vista Orpc with Infomatix Intraop Software	Vista Medical Technologies, Inc.	GCJ	Class II	1999-07-12
K991300	Boeing, Positive Airway Pressure (Pap) Therapy Device	Dhd Healthcare Corp.	BWF	Class II	1999-07-12
K991297	Uni-Laser 450P CO2 Laser System & Accessories	MEDART ApS	GEX	Class II	1999-07-12
K991285	Laser System Rubystar with Q-Switch and Normal Mode	Aesculap-Meditec North America	GEX	Class II	1999-07-12
K991276	Pass/fail Challenge Pack	Propper Mfg Co Inc	JOJ	Class II	1999-07-12
K991272	Cryo-Hit,models Ed1to, Epiti, Ep2ti, Ep2t2, Ep3t3, Ep4t2, Ept3, Ep4t4,ep5t2, Ep5t3, Ep5t5, Ep6t5,ep7t3,ep7t5,ep8t3,and E	Galil Medical Ltd.	GEH	Class II	1999-07-12
K991267	Spine Applications for the Mayfield/acciss Operating Arm and Optical Acciss Systems Module, Mayfield/acciss Spine Ring a	Ohio Medical Instrument Co., Inc.	HAW	Class II	1999-07-12
K990719	Earloop Face Mask	Shuenn Bao Shing Corp.	FXX	Class II	1999-07-12
K990237	Trocar System According to Hasson	OLYMPUS Corporation of the Americas	GCJ	Class II	1999-07-12
K990135	Trilogy Acetabular System Longevity Crosslinked Polyethylene	Zimmer GmbH	LPH	Class II	1999-07-12
K984639	The S-Vna 5-8(B) Diagnostic Ultrasound Transducer	Medison America, Inc.	ITX	Class II	1999-07-12
K984512	Nitrilon Correct-Touch	CT Intl.	KGO	Class I	1999-07-12
K983203	Immulite Epo, Model #'S Lkepz & Lkep1	Siemens Healthcare Diagnostics Inc.	GGT	Class II	1999-07-12
K982943	Transtracheal Demand Oxygen Controller Model Doc-3000	Transtracheal Systems	NFB	Class II	1999-07-12
K982326	Medi-Tech Dialysis Catheter Gastroenterology	Boston Scientific Corporation	MSD	Class II	1999-07-12
K991808	Optibond Solo Plus 2	Sybron Dental Specialties, Inc.	KLE	Class II	1999-07-09
K991789	Atac-Pak Direct Hdl Cholesterol Reagent and Atac Hdl-C Calibrator Kits	Elan Holdings, Inc.	LBR	Class I	1999-07-09
K991774	Acron Mc Modification	GC America Inc.	EBI	Class II	1999-07-09
K991624	Polymer Coat,powder Free, Latex Examination Gloves	Smart Glove Corp. Sdn Bhd	LYY	Class I	1999-07-09
K991605	Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction	Abbott Medical	GKZ	Class II	1999-07-09
K991602	Eptfe Ringed Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1999-07-09
K991554	Glovco, Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)	Glovco (M) Sdn. Bhd.	LYY	Class I	1999-07-09
K991450	Etching Gel	Silicon-Und Composite Spezialitaten GmbH	EBF	Class II	1999-07-09
K991222	Codman Microsensor Ventricular Catheter Kit	Johnson & Johnson Professionals, Inc.	GWM	Class II	1999-07-09
K990843	Serum Crosslaps One Step Elisa	Osteometer Biotech A/S	JMM	Class I	1999-07-09
K990761	Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette	Tuttnauer USA Co. Ltd.	FRG	Class II	1999-07-09
K990649	Glucometer Elite Xl Blood Glucose Meter, Glucometer Elite Blood Glucose Test Systems	Bayer Corp.	CGA	Class II	1999-07-09