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 2026-11-05, 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 1490 of 3531

510(k) clearances, page 1490 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023382	Coopersurgical Malleable Sytlet	CooperSurgical, Inc.	MQF	Class II	2002-12-20
K023353	Sydney Ivf Hyaluronidase	Cook Incorporated	MQL	Class II	2002-12-20
K023193	Candela Gentle Yag Laser System	Candela Corporation	GEX	Class II	2002-12-20
K023160	Drx5000	Axiom USA., Inc.	ITH	Class II	2002-12-20
K023154	Vcs-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02	Vascular Control Systems, Inc.	DXC	Class II	2002-12-20
K022914	Rhythmlink International Subdermal Needle Electrodes	Rhythmlink International, LLC	GXZ	Class II	2002-12-20
K022607	Spectrapulse	Primary Technology, LLC	GEX	Class II	2002-12-20
K022147	Denta Port	J. Morita USA, Inc.	LQY	Unclassified	2002-12-20
K021953	Mitek Pds/pga Staple	Mitek Worldwide	JDR	Class II	2002-12-20
K021826	Trilogy Acetabular System Constrained Liner, Model 6154 Series	Zimmer GmbH	KWZ	Class II	2002-12-20
K021500	Vacuum Assisted Closure	KCI USA, Inc.	OMP	Class II	2002-12-20
K021115	Gyneflex	Naissance Holdings, LC	HIR	Class II	2002-12-20
K013113	Modification to Nanma Vacuum Pump	Nanma Mfg Co., Ltd.	LKY	Class II	2002-12-20
K012691	Monsoon Critical Care Jet Ventilator and Accessories	Acutronic Medical Systems AG	CBK	Class II	2002-12-20
K024098	Cobas Integra Creatinine Plus Ver.2 Assay	Roche Diagnostics GmbH	JFY	Class II	2002-12-19
K024011	Siss Reprocessed Hot Biopsy Forceps, Laparoscopic, Endoscopic and Electrosurgical Surgical Instruments and Accessories	Surgical Instruments Service and Savings, Inc.	NLU	Class II	2002-12-19
K023862	Norian Xr Calcium Phosphate Bone Void Filler	Synthes (USA) Products LLC	MQV	Class II	2002-12-19
K023669	Mas Cardioimmune Tl Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac Tl Low Level Liquid Assayed Cardiac Ma	Medical Analysis Systems, Inc.	JJY	Class I	2002-12-19
K023450	Biopsy Site Tissue Marker Device	Promex, Inc.	NEU	Class II	2002-12-19
K023411	Steelex Sternum Set	Aesculap Inc	GAQ	Class II	2002-12-19
K023280	Olympus Psd-20 Electrosurgical System and Its Associated Accessories	Olympus Optical Co., Ltd.	GEI	Class II	2002-12-19
K023264	Medley Syringe Pump Module System, Model 8110	CareFusion 303, Inc	FRN	Class II	2002-12-19
K023143	Echo Sounder, Es-102Ex	Koven Technology, Inc.	KNG	Class II	2002-12-19
K023137	Philips Easyvision Workstation Release 6	Philips North America LLC	LLZ	Class II	2002-12-19
K022715	Coated Vicryl Plus Antimicrobial (Polyglactin 910) Suture	Ethicon, Inc	GAM	Class II	2002-12-19
K022660	Biocheck Myoglobin Elisa, Model Bc-1117	BioCheck Inc	DRR	Class II	2002-12-19
K021915	Transitional Implants	Intra-Lock International	DZE	Class II	2002-12-19
K021803	Reflection Constrained Liner	Smith & Nephew, Inc.	KWZ	Class II	2002-12-19
K021637	Acell Ubm Lyophilized Wound Dressing	Acell, Inc.	KGN	Unclassified	2002-12-19
K014215	Viabil Biliary Endoprosthesis	W. L. Gore & Associates, Inc.	FGE	Class II	2002-12-19
K024108	Siemens Multi View Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	MHX	Class II	2002-12-18
K024102	Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim	Medtronic, Inc.	LYY	Class I	2002-12-18
K024041	Zetaplus Soft	Zhermack S.p.A.	ELW	Class II	2002-12-18
K024034	Occlufast Rock	Zhermack S.p.A.	ELW	Class II	2002-12-18
K024026	Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color	Shanghai PM Plastics Enterise Co., Ltd.	LYZ	Class I	2002-12-18
K024025	Powder-Free Nitrile Patient Examination Glove, Violet Color	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	2002-12-18
K023996	Aloka Ssd-3500 Ultrasound System	Aloka Co., Ltd.	IYN	Class II	2002-12-18
K023907	Cordis Maxi Ld Large Diameter Balloon Dilatation Catheter, Cordis Maxi Ld Pta Balloon Dilation Catheter	Cordis US Corp.	KNQ	Class II	2002-12-18
K023893	St Aia-Pack Cea Enzyme Immunoassay	Tosoh Medics, Inc.	DHX	Class II	2002-12-18
K023702	Powder-Free Nitrile Exam Gloves, Color: Blue	Ningbo Tianshun Rubber Products Co., Ltd.	LZA	Class I	2002-12-18
K023595	Burette-in Line (150 Ml)	Tuta Healthcare Pty Limited	FPA	Class II	2002-12-18
K023502	Jewel Cast Plus	Pentron Laboratory Technologies	EJH	Class II	2002-12-18
K023501	Gold Core 35	Pentron Laboratory Technologies	EJT	Class II	2002-12-18
K023374	Groshong Nxt Dual Lumen Picc Catheters	C.R. Bard Inc	LJS	Class II	2002-12-18
K023271	Terumo Syringe With/without Needle	Terumo Medical Corp.	FMF	Class II	2002-12-18
K023225	Puritan Bennett Dataflow Data Management Software	Medtronic, Inc.	BZG	Class II	2002-12-18
K023173	Andrews Introducer, Model Asi01	Andrews Surgical Innovations, Ltd.	MDM	Class I	2002-12-18
K023125	Coalescent U-Clip- and Accessories	Coalescent Surgical	NJU	Class II	2002-12-18
K023119	Bi-Cortical Bio Post and Washer, Model Ar-1367B	Arthrex GmbH	HTN	Class II	2002-12-18
K023115	Ace Versanail	Depuy Orthopaedics Inc.	HSB	Class II	2002-12-18