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 2026-10-26, 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 771 of 3530

510(k) clearances, page 771 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141252	Guardian Urethral Sheath	Solace Therapeutics	KNY	Class II	2014-06-09
K140930	Vida LED Surgical Lighting System, V Series	Convida Healthcare & Systems Corporation	FSY	Class II	2014-06-09
K140539	Aero Blue Performance Surgical Gown	Kimberly-Clark Corporation	FYA	Class II	2014-06-09
K140357	Oic Variable Angle Small Fragment Locking Plate System	The Orthopaedic Implant Company	HRS	Class II	2014-06-09
K133012	Sentiero	Path Medical GmbH	EWO	Class II	2014-06-09
K132901	Airsoft F15	ResMed Corp	BZD	Class II	2014-06-09
K131323	Ecleris Sinuscope	Ecleris USA	EOB	Class II	2014-06-09
K141192	Dr 400	AGFA Healthcare Corp.	MQB	Class II	2014-06-06
K141185	V2.7 Software for the Labsystem Pro Ep Recording System	Boston Scientific Corporation	DQK	Class II	2014-06-06
K141060	Chord-X Pre-Measured Loops for Mitral Chordal Replacement	On-X Life Technologies Inc.	PAW	Class II	2014-06-06
K141050	Ensite Velocity System	Abbott Medical	DQK	Class II	2014-06-06
K140972	Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing	Medtronic, Inc.	LDF	Class II	2014-06-06
K140871	Axera 2 Access System	Arstasis, Inc.	DYB	Class II	2014-06-06
K140546	Healgen Thc One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test	Healgen Scientific LLC	LDJ	Class II	2014-06-06
K140353	Starband and Starlight	Orthomerica Products, Inc.	MVA	Class II	2014-06-06
K140112	Ca 125 II Calset II	Roche Diagnostics GmbH	JIT	Class II	2014-06-06
K133774	Atoven	Bio-Med USA, Inc.	GEX	Class II	2014-06-06
K132960	Biomonitor	BIOTRONIK AG	MXD	Class II	2014-06-06
K132415	Rusch Safety Silk Series Oral/nasal Tracheal Tube	Teleflexmedical, Inc.	BTR	Class II	2014-06-06
K132205	Actovox Duo2 Oxygen Concentrator System	Inova Labs, Inc.	CAW	Class II	2014-06-06
K131762	Handheld Monitor	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2014-06-06
DEN120015	Eeva 2.0	Auxogyn, Inc.	PBH	Class II	2014-06-06
K141261	Logiq S7 Expert, Logiq S7 Pro	GE Healthcare	IYN	Class II	2014-06-05
K141006	Rsp Humeral Socket Insert	Djo Global	PHX	Class II	2014-06-05
K140924	Starceram	H.C. Starck Ceramics GmbH	EIH	Class II	2014-06-05
K140868	Stryker Kwic Needle	DSM Biomedical, Inc.	HAW	Class II	2014-06-05
K140602	Flash Penta Mb Quick, Flash Mb Quick	3M Espe AG	ELW	Class II	2014-06-05
K140564	Bn Lumbar Cage System	Medyssey USA	MAX	Class II	2014-06-05
K140481	Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash	Colgate-Palmolive Company	LBH	Class II	2014-06-05
K140434	Medicad Classic	Hectec GmbH	LLZ	Class II	2014-06-05
K140422	Het Systems, Llc, Het Bipolar Ligator System	Het Systems, LLC	GEI	Class II	2014-06-05
K140189	Endowrist Vessel Sealer	Intuitive Surgical, Inc.	NAY	Class II	2014-06-05
K132956	U Fit Dental Implant System	T. Strong Inc.	DZE	Class II	2014-06-05
K131567	Aladdin	VISIA imaging S.r.l.	HJO	Class II	2014-06-05
K141323	Vti Suction Irrigation System	Regulatory Technology Services, LLC	GCJ	Class II	2014-06-04
K140802	Sterispine Ps	Safe Orthopaedics	NKB	Class II	2014-06-04
K133868	Astral Ventilator	ResMed Corp	CBK	Class II	2014-06-04
K133850	Camouflage Nanohybrid Composite (Universal & Flowable)	Prismatik Dentalcraft, Inc.	EBF	Class II	2014-06-04
K132946	Softech Plus Etc02 Cannula	Teleflexmedical, Inc.	CCK	Class II	2014-06-04
K132670	Panpac Inflatable Docut Pessary	Panpac Medical Corporation	HHW	Class II	2014-06-04
K132585	Zibone Ceramic Dental Implant System	Coho Technology Co., Ltd.	DZE	Class II	2014-06-04
K132143	Exhalation Valve	Intersurgical Incorporated	CBP	Class II	2014-06-04
K123126	Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) and # 6512(6532)	Shanghai Motex Healthcare Co., Ltd.	KGO	Class I	2014-06-04
K141147	Range Spinal System	K2M, Inc	NKB	Class II	2014-06-03
K140891	Biomet Cannulated Screw System	Zimmer GmbH	HWC	Class II	2014-06-03
K140683	0180 Intuition, 0072 Precision	Arcoma AB	KPR	Class II	2014-06-03
K140226	Otis-C-Plus, Neotis Plate, Screw 06.5	Science for Biomaterials	HRS	Class II	2014-06-03
K140026	Collasyn Plug for the Lacrimal Efficiency Test	Lacrimedics, Inc.	LZU	Unclassified	2014-06-03
K133349	Smr Tt Metal Back Glenoid	Lima Corporate S.p.A.	KWS	Class II	2014-06-03
K132557	Ewnl Safety Syringe with Needle	Jiamei-Un Co., Ltd.	FMI	Class II	2014-06-03