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 786 of 3530

510(k) clearances, page 786 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132698	Fastouch Fixation System	Via Surgical, Ltd.	GDW	Class II	2014-03-14
K132393	Cercom II Cement	Denali Corporation	EMA	Class II	2014-03-14
K131928	Frend Tsh (Reagent Cartridge)	Nanoentek USA, Inc.	JLW	Class II	2014-03-14
K131899	Sw-Therm	Shenzhen Dongdixin Technology Co., Ltd.	IMJ	Class II	2014-03-14
K131796	Manuka Fill Wound Dressing	Links Medical Products, Inc.	FRO	Unclassified	2014-03-14
K131386	Ez-Ox Plus Generation II	Air Liquide Healthcare America	ECX	Class I	2014-03-14
K140276	Cd Horizon Spinal System	Medtronic Sofamor Danek	OSH	Class II	2014-03-13
K140107	Emerge Medical Distal Radius Set	Emerge Medical	HRS	Class II	2014-03-13
K133832	Klassic Hd Hip System, Offset Femoral Stem, Non-Porous / Porous	Total Joint Orthopedics, Inc.	LPH	Class II	2014-03-13
K133764	Chlorashield IV Dressing with Chg Antimicrobial	Avery Dennison Belgie Bvba	FRO	Unclassified	2014-03-13
K133665	Malleable Suction Instruments	Medtronic Navigation, Inc	PGW	Class II	2014-03-13
K133381	Omni Arc Monoblock Hip Stem	Omni Life Science, Inc.	LZO	Class II	2014-03-13
K133221	Arsenal Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2014-03-13
K133205	Capstone Ptc Spinal System, Clydesdale Ptc Spinal System	Medtronic Sofamor Danek USA Inc	MAX	Class II	2014-03-13
K133097	E-Z Link	Duoject Medical Systems, Inc.	LHI	Class II	2014-03-13
K133015	Instru-Safe Instrument Protection System	Summit Medical, LLC	KCT	Class II	2014-03-13
K133005	Hemosil Von Willebrand Activity Assay	Instrumentation Laboratory Co.	GGP	Class II	2014-03-13
K132752	Ultracongruent Insert	United Orthopedic Corp.	JWH	Class II	2014-03-13
K130501	Intensif	Endymed Medical Inc.	OUH	Class II	2014-03-13
K140405	Torrent Irrigation System	United States Endoscopy Group, Inc.	OCX	Class II	2014-03-12
K140318	Soundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound Catheter	Biosense Webster Inc	OBJ	Class II	2014-03-12
K140119	Emerge Medical Periarticular and Locking Large Fragment System	Emerge Medical	HRS	Class II	2014-03-12
K140098	Emerge Medical Small Fragment Locked Plating System	Emerge Medical	HRS	Class II	2014-03-12
K140064	Surgisleeve Wound Protector	Medtronic, Inc.	KKX	Class II	2014-03-12
K133746	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	NKB	Class II	2014-03-12
K133486	Stellaris Pc Vision Enhancement System	Bausch & Lomb Incorporated	HQC	Class II	2014-03-12
K132080	Snap Wound Care System	Spiracur, Inc.	OKO	Class II	2014-03-12
K131675	Bodihealth System	Eprt Technologies, Inc.	GZJ	Class II	2014-03-12
K130981	Flexstent Biliary Self Expanding Stent System; S.m.a.r.t. Re-Flex Biliary Elf-Expanding Stent System	Cordis US Corp.	FGE	Class II	2014-03-12
K140327	Ultimum Ev Hemostasis Introducer	Abbott Medical	DYB	Class II	2014-03-11
K140248	S Test Reagent Cartridge Carbon Dioxide (CO2)	Canon Medical Diagnostics USA, Inc.	KHS	Class II	2014-03-11
K133755	Kowa Sl-17	Kowa Co., Ltd.	HJO	Class II	2014-03-11
K133483	Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for OTC Use	Portable Therapeutix	IRP	Class II	2014-03-11
K133442	Bone Suppression Software	Eastman Kodak Company	MQB	Class II	2014-03-11
K133401	Syno Mr Neurology, Syngo Mr Oncology, Syngo. Mr Brevis, Syngo Mmr General	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2014-03-11
K133386	Ovation Tribute Hip Stem; Ovation Narrow Hip Stem	Ortho Development Corp.	LPH	Class II	2014-03-11
K133350	Revere Stabilization System	Globus Medical, Inc.	NKB	Class II	2014-03-11
K132736	Accuro 3000 Ultrasound Scanner	Rivanna Medical, Inc	IYO	Class II	2014-03-11
K132322	Newtron P5 Xs B.led	Satelec-Acteon Group	ELC	Class II	2014-03-11
K132094	Cios Alpha	Siemens Medi Cal Solutions, Inc.	OWB	Class II	2014-03-11
K131916	Bprosoft Casp Pc Software	Healthstats International Pte., Ltd.	DXN	Class II	2014-03-11
K131433	Isys 1 (U.s),accessory, Non-Sterile	ISYS Medizintechnik GmbH	JAK	Class II	2014-03-11
K122358	Noveon	Hogan Lovells US LLP	GEX	Class II	2014-03-11
DEN120019	Cefaly	Stx-Med Sprl	PCC	Class II	2014-03-11
K140328	Cmc Mini Tightrope	Arthrex GmbH	HTN	Class II	2014-03-10
K140267	Advia Centaur Tni-Ultra Master Curve Material (Mcm), Advia Centaur Digoxin Master Curve Material (Mcm)	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-03-10
K133864	Dermabond Prineo Skin Closure System	Ethicon, Inc	OMD	Class II	2014-03-10
K133469	Acumed Suture Anchor System	Acumed LLC	MBI	Class II	2014-03-10
K133196	Impact Model 323 Aspirator	ZOLL Medical Corporation	JCX	Class II	2014-03-10
K133104	Van Hip Fracture System	Epix Orthopaedic, Corp.	HSB	Class II	2014-03-10