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 814 of 3530

510(k) clearances, page 814 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132575	Pass Lp Spinal System	Medicrea International	OSH	Class II	2013-10-03
K132554	Aap Loqteq Proximal Medial Tibia Plate 3.5	AAP Implantate AG	HRS	Class II	2013-10-03
K132361	Everest Spinal System	K2M, Inc	MNI	Class II	2013-10-03
K132199	Deroyal Electrosurgical Pencil, Rocker Style without Holster, Deroyal Electrosurgical Pencil, Button Style without Holst	DeRoyal Industries, Inc.	GEI	Class II	2013-10-03
K132183	Dicom Video	Bar Code Computer, Ltd.	LMA	Class II	2013-10-03
K132141	Beautifil Bulk Flowable	Shofu Dental Corp.	EBF	Class II	2013-10-03
K132110	Natus Warmette Blanket and Dual Cabinets	Natus Nicolet Ireland, Ltd.	LGZ	Class II	2013-10-03
K131824	Avaflex Vertebral Balloon System	Care Fusion	HRX	Class II	2013-10-03
K131673	Magnifuse Bone Graft, Magifuse II Bone Graft	Medtronic Sofamor Danek USA Inc	MQV	Class II	2013-10-03
K131625	Anyscan-S Spect Imaging System	Absolute Imaging Solutions	KPS	Class II	2013-10-03
K131617	Colonglide(r) Lubricant	Pediatric Pharmaceuticals, Inc.	KMJ	Class I	2013-10-03
K131583	Thermochem Ht-2000	Thermasolutions LLC.	MLW	Class II	2013-10-03
K131492	Modified Flowgate Balloon Guide Catheter	Concentric Medical, Inc.	DQY	Class II	2013-10-03
K131435	Enseal G2 Tissue Sealer, Straight Jaw, Enseal G2 Tissue Sealer, Curved Jaw, Enseal Trio Tissue Sealer, 3 Mm Curved Jaw,	Ethicon Endo-Surgery Inc	GEI	Class II	2013-10-03
K131368	Neo Knee System	Pipeline Orthopedics	JWH	Class II	2013-10-03
K131042	Ledex	Dentmate Technology Co., Ltd.	EBZ	Class II	2013-10-03
K130947	Fingertip Pulse Oximeter	Beijing Choice Electronic Technololgy Co., Ltd.	DQA	Class II	2013-10-03
K130908	Disposable Silicone Foley Catheter	Guangdong Baihe Medical Technology Co., Ltd	EZL	Class II	2013-10-03
K130525	Occlusion Perfusion Catheter	Advanced Catheter Therapies, Inc.	DQY	Class II	2013-10-03
K130180	Cleanser Root Canal	Cerkamed Wojciech Pawlowski	KJJ	Unclassified	2013-10-03
K122557	Motex Powder-Free Nitrile Surgical Gloves	Shanghai Motex Healthcare Co., Ltd.	KGO	Class I	2013-10-03
K122536	Amcad-Ut Detection Model 2.0	Lin & Associates, LLC	LLZ	Class II	2013-10-03
K132693	BD Veritor™ System Flu A+B Assay	Becton Dickinson & Co	PSZ	Class II	2013-10-02
K132600	Facial Prebent Plating with Virtual Surgical Planning	Biomet Microfixation	JEY	Class II	2013-10-02
K131975	Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace Ldh-L Reagent	Alfa Wassermann Diagnostic Technologies, Inc.	CFJ	Class II	2013-10-02
K131458	Mpact Dm Liner Converter	Medacta International SA	LZO	Class II	2013-10-01
K131251	Trinity Ele	Carol Cole Company	NFO	Class II	2013-10-01
K130020	Access Total Bhcg (5Th Is)	Siemens Healthcare Diagnostics Inc.	DHA	Class II	2013-10-01
K123711	Patient Monitor	Shenzhen Creative Industry Co., Ltd	MWI	Class II	2013-10-01
K132266	Shaser Hrs2 Rx Hair Removal System	Shaser, Inc.	ONF	Class II	2013-09-30
K132097	Best Multi-Lumen Balloon Applicator for Brachytherapy	Best Medical International, Inc.	JAQ	Class II	2013-09-30
K132044	Cranial Loop, Cranial Loop L and Cranial Loop Xl and Cranial Bone Fixation System	Neos Surgery S.L.	GXR	Class II	2013-09-30
K131845	Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh Slide-Loc	Acumed LLC	KWI	Class II	2013-09-30
K131396	Wired Mouth Protector (Wmp)	Elba Laboratories, Inc.	PFL	Class I	2013-09-30
K130573	Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif	Tyber Medical	ODP	Class II	2013-09-30
K132713	Nmi Coaxial Microintroducer Set	Boston Scientific Corporation	DRE	Class II	2013-09-27
K132696	Trusignal Spo2 Adult and Pediatric Adhesive Wrap Disposable Sensor	GE Healthcare Finland Oy	DQA	Class II	2013-09-27
K132659	Volcano Preview Forward-Looking Ivus System	Volcano Corporation	DQY	Class II	2013-09-27
K132630	Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)	Guangzhou Wondfo Biotech Co., Ltd.	DJC	Class II	2013-09-27
K132369	Magellan Robotic System, Magellan Robotic Catheter 9Fr	Hansen Medical, Inc.	DXX	Class II	2013-09-27
K132252	Extricare 100Cc/ 250Cc/ 400Cc Canisters	Devon Medical, Inc.	OMP	Class II	2013-09-27
K132030	Micra Introducer Sheath with Hydrophilic Coating	Medtronic, Inc.	DYB	Class II	2013-09-27
K131860	Vasculab Vl4000 Photoplethysmograph with Pulse Volume Recording	US Vascular	JOP	Class II	2013-09-27
K131656	Morcellex Sigma Generator	Ethicon, Inc	HET	Class II	2013-09-27
K131647	Trinity Acetabular System	Corin USA	LZO	Class II	2013-09-27
K131633	Arthrex Univers Apex	Arthrex GmbH	KWS	Class II	2013-09-27
K131618	Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for Terumo Advanced Perfusion Syst	Terumo Cardiovascular Systems Corporation	DWB	Class II	2013-09-27
K131559	Match Point System(tm), Surgicase Connect, Match Point System(tm) Guides	Materialise N.V.	KWS	Class II	2013-09-27
K131385	Easy-Graft	Degradable Solutions AG	LYC	Class II	2013-09-27
K131206	Cook Cervical Ripening Balloon	Cook Inc.	PFJ	Class II	2013-09-27