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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 837 of 3530

510(k) clearances, page 837 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123082	Mobilect Viewer	Nephosity, Inc.	LLZ	Class II	2013-05-16
K122644	Artis Zee/zeego with Csx-10 Detector Sw Vc21	Siemens Medical Solutions USA, Inc.	OWB	Class II	2013-05-16
K122614	Vintage Mp Press Over	Shofu Dental Corp.	EIH	Class II	2013-05-16
K122124	Portable X-Ray System	OSSTEM Implant Co., Ltd.	EHD	Class II	2013-05-16
K130734	Sauflon Multipurpose Solution	Sauflon Pharmaceuticals, Ltd.	LPN	Class II	2013-05-15
K130463	Ucp Home Drug Screening Test; Cards, Cups	Ucp Biosciences, Inc.	DKZ	Class II	2013-05-15
K130366	Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit	C.R. Bard Inc	DTK	Class II	2013-05-15
K123930	Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and III	Ortho-Clinical Diagnostics, Inc.	LPS	Class II	2013-05-15
K123800	Wrist Automatic Blood Pressure Monitor	Little Doctor Electronic(nantong) Co.,Ltd	DXN	Class II	2013-05-15
K123617	3F Pro-Picc	Medical Components, Inc.	LJS	Class II	2013-05-15
K123586	Easyra Creatinine Reagent	Medica Corp.	CGX	Class II	2013-05-15
K123542	Pascal Synthesis (532Nm/577nm) Opthalmic Laser	Iridex Corporation	HQF	Class II	2013-05-15
K122777	Nbx - Non Bridging External Fixator Hand	NUTEK Orthopaedics, Inc	KTT	Class II	2013-05-15
K122493	Genesisplus	Cutera Inc	GEX	Class II	2013-05-15
K120615	Alere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu Cassette	Alere San Diego Inc. dba Biosite,Innovacon,Hemosen	CGA	Class II	2013-05-15
K131107	Atriclip Gillinov-Cosgrove Laa Clip	AtriCure, Inc.	FZP	Class II	2013-05-14
K130729	Extra Corporeal Shockwave Lithotripter	Dornier Medtech Systems	LNS	Class II	2013-05-14
K130479	Ilizarov Drill Tip Wires	Smith & Nephew, Inc.	KTT	Class II	2013-05-14
K124022	Speed Shift	Biomedical Enterprises, Inc.	JDR	Class II	2013-05-14
K123985	Sensus Healthcare Superficial Radiotherapy System Srt-100	Sensus Healthcare	JAD	Class II	2013-05-14
K123912	Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set	Spencer Fillmore	JAQ	Class II	2013-05-14
K123551	Itclamp 50	Innovative Trauma Care Inc	DXC	Class II	2013-05-14
K123077	Vascular Clamps	Hebumedical GmbH	DXC	Class II	2013-05-14
K122785	Hydrosil; Magic; Personal Catheter	Rochester Medical Corp.	EZD	Class II	2013-05-14
K131099	Ag Mass	Hospitech Respiration	JCX	Class II	2013-05-13
K130506	Imse P-Tlif	Institute of Musculoskeletal Science & Education	MAX	Class II	2013-05-13
K130282	Remington Medical Centrefire 22 Biopsy Instrument	Remington Medical	KNW	Class II	2013-05-13
K130159	Qlab Quantification Software Heart Model	Philips Health Care	LLZ	Class II	2013-05-13
K124058	Creo Stabilization System	Globus Medical, Inc.	OSH	Class II	2013-05-13
K123913	Latis Spacer	Globus Medical, Inc.	MAX	Class II	2013-05-13
K123903	BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)	Becton Dickinson & Co	MDB	Class I	2013-05-13
K123629	Finessis Polyisoprene Powderfree Surgical Gloves	Lucenxia Prescience AG	KGO	Class I	2013-05-13
K122635	Tornier Insite Ft Biocomposite Suture Anchor	TORNIER Inc.	MAI	Class II	2013-05-13
K122013	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (Bp4gapo-2M)	Microlife Corp.	DXN	Class II	2013-05-13
K120756	Lsh (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, Lsh (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact Le	The Lagado Corp.	LPL	Class II	2013-05-13
K130617	Raystation	RaySearch Laboratories AB (publ)	MUJ	Class II	2013-05-10
K130289	Trc-Nw8 Non-Mydriatic Retinal Camera	Topcon Corp.	HKI	Class II	2013-05-10
K130192	Nextstep Retrograde	Arrow International LLC (subsidiary of Teleflex Incorporated)	MSD	Class II	2013-05-10
K123871	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2013-05-10
K123769	Zx-I Power Add on	Spinergy, Inc.	ITI	Class II	2013-05-10
K123478	Stingray Bipolar Forceps	Stingray Surgical Products	GEI	Class II	2013-05-10
K123381	Hyperion X9	Cefla S.C.	OAS	Class II	2013-05-10
K121719	Sm TENS & Pms	Hong Qiangxing (Shenzhen) Electronics Limited	NGX	Class II	2013-05-10
K121467	Eurotrol Hematocrit Control	Eurotrol B.V.	GLK	Class II	2013-05-10
K121203	Boston Keratoprosthesis or Boston Kpro	Massachusetts Eye & Ear Infirmary	HQM	Class II	2013-05-10
K131038	Nmi Picc Maximal Barrier Nursing Kits	Boston Scientific Corporation	LJS	Class II	2013-05-09
K131030	Range Spinal System	K2M, Inc	OSH	Class II	2013-05-09
K131020	Temperature Sensor Catheter	Degania Silicone, Inc.	EZL	Class II	2013-05-09
K130990	Variant(tm) II Turbo Hba1c Kit - 2.0	Bio-Rad Laboratories, Inc., Clinical Systems Divis	LCP	Class II	2013-05-09
K130830	Integra Laminoplasty System	Seaspine, Inc.	NQW	Class II	2013-05-09