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 2026-11-02, 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 992 of 3531

510(k) clearances, page 992 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K102035	Sleek Otw Pta Catheters	Clearstream Technologies Ltd.	LIT	Class II	2010-12-01
K101923	Concorde Curve System	DePuy Spine, Inc.	MAX	Class II	2010-12-01
K101428	Otsc (Over-the Scope-Clip) System Set	Ovesco Endoscopy AG	PKL	Class II	2010-12-01
K100504	V-Go Disposable Insulin Delivery Device, Model# V-Go 20, V-Go 30, V-Go40	Valeritas, Inc.	LZG	Class II	2010-12-01
K093908	Ccpoint	Svar Life Science AB	NHX	Class II	2010-12-01
K102682	Staxx(r) Xd System	Spine Wave Inc	MQP	Class II	2010-11-30
K102638	Diazyme Homocysteine Assay Buffer Based Calibrators	Diazyme Laboratories, Inc.	JIT	Class II	2010-11-30
K102790	Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis Potential and Chemotherapy Drug	Perusahaan Getah Asas Sdn. Bhd.	LZC	Class I	2010-11-29
K102360	Icesence 3	Icecure Medical Ltd	GEH	Class II	2010-11-29
K101794	Asc Triport Laparoscopic Access Device Model Tprt-02-01 (Wa58000t), Asc Quadport Laparoscopic Asscess Device Qprt-01 (Wa	Advanced Surgical Concepts	OTJ	Class II	2010-11-29
K101590	Digital Flat Panel X-Ray Detector	Vatech Co., Ltd.	MQB	Class II	2010-11-29
K100920	Mesa II Oxygen Concentrator Model: T2000 Series	Sequal Technologies, Inc.	CAW	Class II	2010-11-29
K100586	Venus Freeze System	Venus Concept Inc.	GEI	Class II	2010-11-29
K100487	Equinox CO2 Laser System	Eclipsemed Global, Inc.	ONG	Class II	2010-11-29
K093626	Innovance D-Dimer, Model Opbp09	Siemens Healthcare Diagnostics Inc.	DAP	Class II	2010-11-29
K102548	Footprint Medical Polyurethane Feeding Tube	Footprint Medical Inc.	KNT	Class II	2010-11-26
K101784	Mobicath Bi-Directional Guiding Sheath Model 1000182-Xxx	Great Batch Medical	DYB	Class II	2010-11-26
K100199	Angiodynamics, Inc., Percutaneous Introducer and Venacureevlt Procedure Kit	Boston Scientific Corporation	GEX	Class II	2010-11-26
K102690	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2010-11-24
K102505	Hto Plating System	Aesculap Inc	HRS	Class II	2010-11-24
K102349	Aerodr System	Konica Minolta Medical & Graphic, Inc.	KPR	Class II	2010-11-24
K102234	A-Dec 200 Dental System	A-dec, Inc.	EIA	Class I	2010-11-24
K102170	Simplexa Flu A/b & Rsv	DiaSorin Molecular LLC	OCC	Class II	2010-11-24
K101539	Vital Signs Monitor Model M3b	Edan Instruments, Inc.	DQA	Class II	2010-11-24
K101534	Conmed Altrus Thermal Tissue Fusion System	Conmedcorp	GEI	Class II	2010-11-24
K101471	Axle Interspinous Fusion System	Xtant Medical Holdings, Inc.	KWP	Class II	2010-11-24
K100628	Plasmaluxls	The Daavlin Distributing Co.	ONE	Class II	2010-11-24
K100246	Max-If1000	Bio Protech, Inc.	LIH	Class II	2010-11-24
K093599	Arrow Anatomical Shoulder System	Fournitures Hospitalieres Industrie	KWS	Class II	2010-11-24
K103269	Patchassist Large	Polytouch Medical, Ltd.	ORQ	Class II	2010-11-23
K103268	Omni Express	Infinium Medical, Inc	MWI	Class II	2010-11-23
K103202	Preassembled Surgical Wash Set	Corcym Inc.	CAC	Class II	2010-11-23
K102904	Enhanced Estradiol (Ee2) Master Curve Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2010-11-23
K102849	Acculmaing	Radiology Information Systems, Inc.	LLZ	Class II	2010-11-23
K102802	Integra Electrode Tunneling Needle	Integra LifeSciences Corporation	GYC	Class II	2010-11-23
K102791	Easysuite Surgical Light Control (Eslc)	Image Stream Medical, Inc.	FTA	Class II	2010-11-23
K102429	Ortholoc 3Di Ankle Plating System, Ortholoc Bone Screw	Wrightmedicaltechnologyinc	HRS	Class II	2010-11-23
K102343	Emerge Medical Cannulated Screw Fixation System	Emerge Medical	HWC	Class II	2010-11-23
K102339	Conmed Linvatec Sequent Meniscal Repair Device	Conmed Linvatec	GAT	Class II	2010-11-23
K102255	Dmp Etching Gel	Dmp, Ltd.	EBF	Class II	2010-11-23
K102254	Dmp Single Bonding	Dmp, Ltd.	KLE	Class II	2010-11-23
K102237	Pvs Model 1.0	Medcom GmbH	IYE	Class II	2010-11-23
K102207	Fiber Force	Synca Marketing	EBI	Class II	2010-11-23
K102202	Gs 3000	Emsi	IPF	Class II	2010-11-23
K102108	Clickfine Pen Needle	Ypsomed AG	FMI	Class II	2010-11-23
K102080	Depuy Reclaim Revision Hip System	Depuy (Ireland)	LZO	Class II	2010-11-23
K101574	Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control Model5025-0001-00, 5025-0002-00, 5025-0003-0	Ark Diagnostics Inc	OTF	Class II	2010-11-23
K101291	Scanview Her2/neu Fish System	Applied Spectral Imaging, Ltd.	NTH	Class II	2010-11-23
K101163	Biogel Orthopro Indicator Underglove	Molnlycke Health Care USA	KGO	Class I	2010-11-23
K100721	Locking Bone Screw Model Hcq04, Hcz04	Changzhou Orthmar Medical Instrument Co., Ltd.	HWC	Class II	2010-11-23