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 791 of 3530

510(k) clearances, page 791 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132953	Tidisheild	Tidi Products, LLC	PEM	Class II	2014-02-18
K132451	Sarns Soft-Flow Aortic Cannula	Terumo Cardiovascular Systems Corporation	DWF	Class II	2014-02-18
K131898	A Series and Q Series Patient Monitors	Guangdong Biolight Meditech Co., Ltd	MWI	Class II	2014-02-18
K130891	Powder Free Vinyl Patient Examination Gloves	Friend Plastic Co., Ltd.	LYZ	Class I	2014-02-18
K130809	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Jewel Plastic Co., Ltd.	LYZ	Class I	2014-02-18
K130800	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Kaixuan Plastic Co., Ltd.	LYZ	Class I	2014-02-18
K130385	Compressible Limb Sleeve System	Maxstar Industrial Co Ltd	IRP	Class II	2014-02-18
K140136	Nipro Safetouch Psv Scalp Vein Set with Safety Device	Nipro Medical Corporation	FOZ	Class II	2014-02-14
K140108	3Mp Color Lcd Display	Shenzhen Beacon Display Technology Co., Ltd.	LLZ	Class II	2014-02-14
K140103	3Mp Grayscake Lcd Display	Shenzhen Beacon Display Technology Co., Ltd.	LLZ	Class II	2014-02-14
K134004	Verizon Wireless Converged Health Management Device	Cellco Partnership D/B/A Verizon Wireless	DRG	Class II	2014-02-14
K133708	Md302c4 29.8 Diagnostic Imaging Lcd Monitor	Nec Display Solutions, Ltd.	LLZ	Class II	2014-02-14
K133629	Angiojet Ultra Avx Thrombectomy Set	Possis Medical, Inc.	QEW	Class II	2014-02-14
K133450	Airstrip Remote Patient Monitoring	AirStrip Technologies, Inc.	MWI	Class II	2014-02-14
K133335	Powerport Implantable Port	C.R. Bard Inc	LJT	Class II	2014-02-14
K133296	Xcath	Alseal	DYB	Class II	2014-02-14
K133242	Stellaris Vision Enhancement System	Bausch & Lomb Incorporated	HQC	Class II	2014-02-14
K132909	Bd Phoenix Automated Microbiology System Tigecycline (0.25-16 Ug/ml)	Becton Dickinson & Co	LON	Class II	2014-02-14
K132649	Reveal Linq Insertable Cardiac Monitor	Medtronic, Inc.	MXD	Class II	2014-02-14
K132534	Victus Femtosecond Laser Platform	Technolas Perfect Vision GmbH	OOE	Class II	2014-02-14
K132426	Sylphar Remesense Sensitivity Relief Strips	Sylphar N.V.	LBH	Class II	2014-02-14
K132212	Dental Bone Screws; Dental Bone Screws, Continuing; Screw System Tx; Screw System Tx Professional	Hager & Meisinger GmbH	DZL	Class II	2014-02-14
K132192	Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator	Bracco Diagnostic, Inc.	FCX	Class II	2014-02-14
K131266	Trez_hd	Excel-Tech Ltd. (Xltek)	GWQ	Class II	2014-02-14
K131260	Nmi Dialysis Catheter	Boston Scientific Corporation	MSD	Class II	2014-02-14
K130781	L.a.m. Ipm Wound Gel, Ipm Derm Gel	Glycobiosciences, Inc.	FRO	Unclassified	2014-02-14
K140104	Barricade Embolization Coil System	Blockade Medical	HCG	Class II	2014-02-13
K132832	Activapatch Et Iontophoresis Patch	Activatek, Inc.	EGJ	Class II	2014-02-13
K132422	Pals Platinum Neurostimulation Electrodes	Axelgaard Mfg. Co., Ltd.	GXY	Class II	2014-02-13
K132257	Manual Wheelchair	Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.	IOR	Class I	2014-02-13
K130633	Introducer Sets, Model Adelante Radial	Oscor Inc.	DYB	Class II	2014-02-13
K140116	Restorelle Y Contour Mesh	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2014-02-12
K140102	Physioflow Q-Link	Vasocom, Inc.	DSB	Class II	2014-02-12
K133533	Logiq E	GE Healthcare	IYN	Class II	2014-02-12
K133526	Mdixon-Quant	Philips Medical Systems Nederland B.V.	LNH	Class II	2014-02-12
K133476	Slit Lamps with Sl Cam 5.0 Digital Imaging Solution	Carl Zeiss Meditec Inc	HJO	Class II	2014-02-12
K133352	Hypersound Audio System (Hss)	Hypersound Health, Inc.	EPF	Class II	2014-02-12
K133293	15 Fr. Tandemheart Arterial Cannula	Cardiacassist, Inc.	DWF	Class II	2014-02-12
K133274	Vena Pro	Innovamed Health, LLC	JOW	Class II	2014-02-12
K133273	Liger Medical Esu-110	Liger Medical	GEI	Class II	2014-02-12
K133201	Shaser V-Mini 2 Hair Removal System	Shaser, Inc.	ONF	Class II	2014-02-12
K132991	C-Box Peek Cervical Ibf	Innovasis, Inc	ODP	Class II	2014-02-12
K132720	Heartspan Fixed Curve Braided Transseptal Sheath	Merit Medical Systems, Inc.	DYB	Class II	2014-02-12
K132582	Exactech Acapella One Cervical Spacer System	Exactech, Inc.	OVE	Class II	2014-02-12
K132464	PTFE Surgical Suture	Omnia SpA	NBY	Class II	2014-02-12
K132424	Metrixcare	The Metrix Company	KNT	Class II	2014-02-12
K131882	Geodesiceeg System 400 Series (Ges 400)	Electrical Geodesics, Inc.	OLT	Class II	2014-02-12
K131552	Conventus Drs	Conventus Orthopaedics, Inc.	HRS	Class II	2014-02-12
K131454	Klassic Hd(tm) Extended Offset Femoral Head	Total Joint Orthopedics, Inc.	LPH	Class II	2014-02-12
K131154	Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 Ml Bag Enteral Delivery Set;	Zevex, Inc.	LZH	Class II	2014-02-12