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 1020 of 3531

510(k) clearances, page 1020 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093102	Ambulatory Blood Pressure Monitor, Models Fb-270 and Ds-270	Nihon Seimitsu Sokki Co., Ltd.	DXN	Class II	2010-06-03
K092667	Global Dmso Blastocyst Vitrification Kit and Warming Kit	<Genx> Intl., Inc.	MQL	Class II	2010-06-03
K091859	Aesku Pr3	Aesku Diagnostics	MOB	Class II	2010-06-03
K101239	Viewflex Plus Ice Catheter	Abbott Medical	DQO	Class II	2010-06-02
K101221	Jetstream G3 System, Model Pv31300, Pv Console, Model Pvcn100	Pathway Medical Technologies, Inc.	MCW	Class II	2010-06-02
K100905	Hydrofix Surgical Sheet	Mimedx Group, Inc.	OMR	Class II	2010-06-02
K100756	Malta	3M Espe AG Dental Products	EMA	Class II	2010-06-02
K100563	Geon Rapid Digital Thermometer Model: Mt-B117, Mt-B127, Mt-B130, Mt-B132fa	Geon Corporation	FLL	Class II	2010-06-02
K100175	Clydesdale Spinal System	Medtronic Sofamor Danek	MAX	Class II	2010-06-02
K100822	Xpert Mrsa/sa Nasal Assay	Cepheid	NQX	Class II	2010-06-01
K091281	Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, Ultra	Procter & Gamble Co.	HEB	Class II	2010-06-01
K101275	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch Bp Office Afib (Twin200 Afs).	Microlife Intellectual Property GmbH	DXN	Class II	2010-05-28
K100617	Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D	Masimo Corporation	DQA	Class II	2010-05-28
K100606	Vatea Endontic Irrigation System	Redent Nova, Ltd.	NYL	Class I	2010-05-28
K100554	Respiratory Humidifier , Heated Delivery System, Adaptor, Models Mr880, Rt241, 900Mr441	Fisher & Paykel Healthcare, Inc.	BTT	Class II	2010-05-28
K100435	Ameda Platinum Breast Pump	Evenflo Company, Inc.	HGX	Class II	2010-05-28
K100427	Fora Gw 9014 Telehealth Gateway/td-9014 Telehealth Gateway	Taidoc Technology Corporation	DRG	Class II	2010-05-28
K100254	Reprocessed Cs Bi-Diectional Diagnostic Electrophysiology Catheter	Stryker Sustainability Solutions	NLH	Class II	2010-05-28
K100151	Apex Hip System Bipolar Head, Model H3-822Xx (Od 38 to 43Mm), H3-828Xx (Od44 to 60Mm)	Omnlife Science	KWY	Class II	2010-05-28
K093264	Vinyl Examination Glove, Powder Free, Non-Colored	Qingdao Lang Hui Import & Export Co., Ltd.	LYZ	Class I	2010-05-28
K092705	Abbott M2000sp and Abbott M2000rt, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501	Abbott Molecular, Inc.	OOI	Class II	2010-05-28
K092704	Abbott Realtime Ct/ng and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91, 9K12-03	Abbott Molecular, Inc.	LSK	Class I	2010-05-28
K092608	Synthetic Mineral-Collagen Bone Graft Matrix	Collagen Matrix, Inc	MQV	Class II	2010-05-28
K092117	Scenar, Model 10	Ritm Okb Zao	GZJ	Class II	2010-05-28
K090386	Non-Invasive Infrared (Nir)	Medisim Ltd.	FLL	Class II	2010-05-28
K100857	Fusion Medical Ring Lock System	John J Riccio	KTT	Class II	2010-05-27
K100269	Novation Crown Cup Gxl Liners	Exactech, Inc.	LPH	Class II	2010-05-27
K093902	Modification To:fresenius 2008T Hemodialysis Machine, Model 190573	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2010-05-27
K093275	Exactech Equinoxe Reverse Shoulder System 36Mm Glenosphere and Humeral Liner	Exactech, Inc.	PHX	Class II	2010-05-27
K092187	Maia, Model 1	Centervue	HPT	Class I	2010-05-27
K091168	Glucophone Blood Glucose Test System, Model Igm-0025	Infopia Co, Ltd.	NBW	Class II	2010-05-27
K090191	Handylab Gbs Assay, Handylab Jaguar Instrument, Handylab DNA Extraction Strip, Handylab E3 Extraction Reagent, Handylab	Handylab, Inc.	NJR	Class I	2010-05-27
K101143	Heartway Power Mobility Scooter, S11	Heartway Medical Products Co., Ltd.	INI	Class II	2010-05-26
K101142	Heartway Lightweight Power Mobility Scooter, S34	Heartway Medical Products Co., Ltd.	INI	Class II	2010-05-26
K100942	U-Right Ear Themometer, Models Td-1115 and Td-1118	Taidoc Technology Corporation	FLL	Class II	2010-05-26
K100913	Iqvitals and Iqvitals System	Brentwood Medical Technology Corp.	DXN	Class II	2010-05-26
K100878	Self Cath Catheter	MEDLINE INDUSTRIES, LP - Northfield	EZD	Class II	2010-05-26
K100656	Compressible Limb Therapy System Model Whf-324 (Power-Q1000 Plus)	Wonjin Mulsan Co., Ltd.	IRP	Class II	2010-05-26
K100637	Syngo.ct Coronary Analysis	Siemens AG Medical Solutions	JAK	Class II	2010-05-26
K093973	Trufill Dcs Orbit Detachable Coil System	Cerenovus, Inc.	HCG	Class II	2010-05-26
K090379	Avita Nasal Aspirator, Model, Ns1 Series	Avita Corporation	BTA	Class II	2010-05-26
K100824	Mechanical Wheelchair, Model Ds 202-S	Suzhou KD Medical	IOR	Class I	2010-05-25
K100553	Blood Pressure Meter Model Ch-101	Citizen Systems Japan Co., Ltd.	DXN	Class II	2010-05-25
K100150	Ceramics2in1	Biodenta Swiss AG	EIH	Class II	2010-05-25
K093405	Prophecy Pre-Operative Navigation Alignment Guides	Wrightmedicaltechnologyinc	MBH	Class II	2010-05-25
K093390	Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025	DePuy Spine, Inc.	LYC	Class II	2010-05-25
K092021	Cryovalve Sg Pulmonary Human Heart Valve (and Conduit)	Artivion, Inc.	OHA	Unclassified	2010-05-25
K101011	Hi-Torque Balance Middleweight Universal	Abbott Vascular	DQX	Class II	2010-05-24
K100524	Polytel(r) Apt Model: Pwa-08-01	Polymap Wireless	DRG	Class II	2010-05-24
K100148	Simplexa Influenza a H1n1 (2009) Model Mol2500	DiaSorin Molecular LLC	OQW	Class II	2010-05-24