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 1364 of 3531

510(k) clearances, page 1364 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K042708	Era 3000 Pacing System Analyzer	BIOTRONIK AG	DTE	Class II	2004-10-20
K042706	Ossatura Dental	IsoTis OrthoBiologics, Inc.	LYC	Class II	2004-10-20
K042669	Ionofil Plus Ac	Voco GmbH	EMA	Class II	2004-10-20
K042658	Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004	Nobel Biocare Uas, Inc.	NHA	Class II	2004-10-20
K042484	Nai Tech Products Medical Digital Recorder	Nai Technology Products	LMA	Class II	2004-10-20
K042383	Rsa-Cms	Medis Medical Imaging Systems, B.V.	LLZ	Class II	2004-10-20
K042369	Sonoscape Ultrasound System Ssi-1000/Ssi-5000	Sonoscape Company Limited	IYN	Class II	2004-10-20
K042200	Mi Paste	GC America Inc.	EJR	Class I	2004-10-20
K042071	Ibd-Scan	Techlab, Inc.	DEG	Class I	2004-10-20
K042002	Synescope, Easyscope, Synecom, Holterreader	Ela Medical, Inc.	DQK	Class II	2004-10-20
K041988	Arthrotek Meniscal Hybrid Device	Zimmer GmbH	JDR	Class II	2004-10-20
K041963	American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi	American Bantex Corp.	BTT	Class II	2004-10-20
K041961	Scandius Absorbable Acl Reconstruction System	Scandius Biomedical, Inc.	HWC	Class II	2004-10-20
K041068	West Nile Virus Igg Indirect Elisa	Panbio Limited	NOP	Class II	2004-10-20
K031832	Mega Pure Cart	Mega Services	FIP	Class II	2004-10-20
K042781	Ipacs Cardio	Realtimeimage, Inc.	LLZ	Class II	2004-10-19
K042741	Ec-3870Cilk, Confocal Video Colonoscope	PENTAX of America, Inc.	GCJ	Class II	2004-10-19
K042740	Isc-1000 Pentax Confocal Laser System	PENTAX of America, Inc.	GCJ	Class II	2004-10-19
K042674	Colon Car 1.2	Medicsight	NWE	Class II	2004-10-19
K042646	Dynact	Siemens Medical Solutions USA, Inc.	IZI	Class II	2004-10-19
K042587	Retic-Chex for Cell-Dyn	Streck Laboratories, Inc.	JPK	Class II	2004-10-19
K042539	Gdc-10 360 Degree Coil Sr; Gdc-10 360 Degree Soft Coil Sr; Gdc-18 360 Degree Coil	Boston Scientific Corporation	HCG	Class II	2004-10-19
K042494	Vitros Chemistry Products C3 and Cr Reagent, Calibrator Kit 20, Protein Performance Verifiers I, II, and III	Ortho-Clinical Diagnostics, Inc.	CZW	Class II	2004-10-19
K042492	Hand Stc, Model 60Mm	Niti Medical Technologies, Ltd.	GDW	Class II	2004-10-19
K042465	Ps Medical Strata II Valve	Medtronic Neurosurgery	JXG	Class II	2004-10-19
K042445	Site-Rite Needle Guide Kits and Probe Cover Kit	Bard Access Systems, Inc.	ITX	Class II	2004-10-19
K042391	Kolibri Image Guided Surgery System	Brainlab, Inc.	HAW	Class II	2004-10-19
K042031	Opus Speedstitch Suture Device	Opus Medical, Inc.	GAT	Class II	2004-10-19
K041969	Aurora Ds	Syneron Medical, Ltd.	GEX	Class II	2004-10-19
K040866	First Response One-Step Digital Pregnancy Test	Armkel, LLC	LCX	Class II	2004-10-19
K040839	Complete Blink-N-Clean Lens Drops	Advanced Medical Optics, Inc.	MRC	Class II	2004-10-19
K042800	Lifecare Pca Infusion System with Hospira Mednet Software	Abbott Medical	MEA	Class II	2004-10-18
K042627	Ear Thermometer Models St61, St62, St63, St64, and St65	Mesure Technology Co., Ltd.	FLL	Class II	2004-10-18
K042608	Tecno Reusable Bipolar Cables, Model 190-100 and 190-110	Tecno Instruments (Pvt.) Ltd.	GEI	Class II	2004-10-18
K042573	Kls Martin Drill-Free Mmf Screw	KLS-Martin L.P.	DZL	Class II	2004-10-18
K042206	Purple/black Heparin Assay Control	Medtronic, Inc.	GGN	Class II	2004-10-18
K042175	Heparinase Hr Act Control, Model 550-12	Medtronic, Inc.	GGN	Class II	2004-10-18
K042165	Cutera Tabletop Aesthetic Product	Cutera Inc	ILY	Class II	2004-10-18
K041272	Dyract Cem Plus Cement	Dentsply Intl.	EMA	Class II	2004-10-18
K041018	Drg Softrelease	Doctor'S Research Group, Inc.	HHT	Class II	2004-10-18
K040485	Maxair Surgical Helmet System	Bio-Medical Devices, Inc.	FYA	Class II	2004-10-18
K034017	Jeje Teether	Vibe 2000	MEF	Class I	2004-10-18
K033943	Alpha Metasul 28Mm and 32Mm Acetabular Inserts, Standard and Hooded	Centerpulse Orthopedics, Inc.	KWA	Class III	2004-10-18
K042771	Ge Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3	GE Healthcare	MSX	Class II	2004-10-15
K042712	Tamper Evident Ultrasafe Passive Delivery System	Safety Syringes, Inc.	MEG	Class II	2004-10-15
K042593	Acuson Acunav 8F Ultrasound Catheter	Siemens Medical Solutions USA, Inc.	OBJ	Class II	2004-10-15
K042568	Excelsior 1018 and Sl-10 Microcatheters	Boston Scientific Corporation	DQY	Class II	2004-10-15
K042493	Ensite System, Model Ee3000	Endocardial Solutions, Inc.	DQK	Class II	2004-10-15
K042306	Philips Sp02 Disposable Sensor, Model M1131a	Philips Medizin Systeme Boeblingen GmbH	DQA	Class II	2004-10-15
K041975	Validate Lipoprotein Calibration Verification Test Set, Model 501	Maine Standards Co.	JJY	Class I	2004-10-15