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 867 of 3530

510(k) clearances, page 867 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121846	Contiplex C Continuous Peripheral Nerve Block Needle	B.Braun Medical, Inc.	BSP	Class II	2012-11-20
K121757	Healthmateforever	Healthmate International, LLC	NUH	Class II	2012-11-20
K121712	Airstrip Rpm for Lifenet Consult	AirStrip Technologies, Inc.	MSX	Class II	2012-11-20
K121603	Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3	Randox Laboratories, Limited	JJY	Class I	2012-11-20
K121546	Vitek 2 Gram Negative Doxycycline	bioMerieux, Inc.	LON	Class II	2012-11-20
K121499	Fujifilm Tomosynthesis Option for Fdr Acselerate Stationary X-Ray System	FUJIFILM Healthcare Americas Corporation	IZF	Class II	2012-11-20
K121365	Thermoformed Mouthguards	Glidewell Laboratories-Sleep Devices Group	MQC	Unclassified	2012-11-20
K121234	Gore(r) Dryseal Sheath with Hydrophilic Coating	W. L. Gore & Associates, Inc.	DYB	Class II	2012-11-20
K121220	Equinoxe Glenoid, Uhmwpe 16 Ps=osterior Augment Pegged, Small, Left/right	Exactech, Inc.	KWS	Class II	2012-11-20
K121085	Het Bipolar Ligator System	Het Systems, LLC	GEI	Class II	2012-11-20
K113315	Rumble Tuff	Acute Ideas Co., Ltd.	HGX	Class II	2012-11-20
DEN100023	Ahip Internal Trigger Point Wand Model: 1	National Center for Pelvic Pain Research Devices	OSD	Class II	2012-11-20
K122699	Sentrysuite Product Line	Carefusion Germany 234 GmbH	BTY	Class II	2012-11-19
K122538	Acumed Pelvic Bone Plate System	Acumed LLC	HRS	Class II	2012-11-19
K122440	Restorelle L	MEDLINE INDUSTRIES, LP - Northfield	OTO	Class II	2012-11-19
K122356	Alivecor Heart Monitor for Iphone	AliveCor	DPS	Class II	2012-11-19
K122333	Mobilecare Monitor	Aframe Digital, Inc.	DRG	Class II	2012-11-19
K121791	Zou Anterior Lumbar Plate System	Corelink, LLC	KWQ	Class II	2012-11-19
K121494	Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5 T25, Self-Tapping	AAP Implantate AG	HRS	Class II	2012-11-19
K121100	Vitek 2 Ast Streptococus Vancomycin	bioMerieux, Inc.	LON	Class II	2012-11-19
K120711	Non-Contact Thermometer	K-Jump Health Co., Ltd.	FLL	Class II	2012-11-19
K120617	PTFE Super Sheath Introducer	Martech Medical Products	DYB	Class II	2012-11-19
K113567	Synthes Matrixmadible Plate and Screw System	Synthes GmbH	JEY	Class II	2012-11-19
K123246	Cd Horizon Spire Z Spinal System	Medtronic Sofamor Danek	NKB	Class II	2012-11-16
K123174	Centricity Pacs-Iw with Universal Viewer	GE Healthcare	LLZ	Class II	2012-11-16
K123026	Textured, Blue, Latex, Powder Free Examination Glvoes, with Protein Labeling Claim (50Ug/dm or Less of Water Soluble Pro	Northstar Healthcare Holdings	LYY	Class I	2012-11-16
K122729	Abl90 Flex	Radiometer Medical ApS	CHL	Class II	2012-11-16
K122686	Accu-Chek Ultraflex Infusion Set	Roche Diabetes Care, Inc.	FPA	Class II	2012-11-16
K122529	Zimmer Unicompartmental Knee System Vivacit-E Articular Surface	Zimmer GmbH	HSX	Class II	2012-11-16
K122526	360 Gas Assisted Endoscopic Applicator	Micromedics, Inc.	GCJ	Class II	2012-11-16
K122236	Varisourse IX Brahytherapy Afterloader Varisource IX (T) Brachytherapy Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	2012-11-16
K122174	Pediatric Positioner Pad Set	GE Healthcare Coils (USA Instruments, Inc.)	KXH	Class I	2012-11-16
K122171	Ms Sa Implant System	OSSTEM Implant Co., Ltd.	DZE	Class II	2012-11-16
K122129	Sphygmocor Xcel	ATCOR MEDICAL Pty Ltd	DXN	Class II	2012-11-16
K122008	Incite Anchored Cervical Interbody (Aci) Fusion Device	Incite Innovation, LLC	OVE	Class II	2012-11-16
K121792	Neuviz 64 Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	JAK	Class II	2012-11-16
K121225	Hamilton-C2	Hamilton Medical AG	CBK	Class II	2012-11-16
K121151	Pro-Link Cervical Spacer System	Life Spine	OVE	Class II	2012-11-16
K120066	Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored. Non-Sterile, Low Dermatitis Potential	Kossan Latex Industries (M) Sdn Bhd	LZA	Class I	2012-11-16
K113344	Stereos Workstation	EOS imaging	LLZ	Class II	2012-11-16
K113113	Endosseous Dental Implant	OT Medical GmbH	DZE	Class II	2012-11-16
K123259	Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) System	Devicor Medical Products Inc	KNW	Class II	2012-11-15
K122904	Wondfo Multi-Drug Urine Test Cup Model W2002-Cu; W2003-Cu; W2004-Cu; W2005-Cu; W2006-Cu; W2007-Cu; W2008-Cu; W2009-Cu;	Guangzhou Wondfo Biotech Co., Ltd.	DKZ	Class II	2012-11-15
K122899	Powerport Clearvue Slim Implantable Port	C.R. Bard Inc	LJT	Class II	2012-11-15
K122886	Nexstat Plus and Nexfoam Plus Topical Hemostat Dressing	Hemostasis, LLC	QSY	Unclassified	2012-11-15
K122090	Sjm Confirm Implantable Cardiac Monitor	St. Jude Medical, Cardiac Rhythm Management Divisi	MXC	Class II	2012-11-15
K122011	Navigation Software Hip-Universal; Navigation Software Hip Thr-Aesculap	Brainlab, Inc.	OLO	Class II	2012-11-15
K121857	Femmycycle	Femcap Incorporated	HHE	Class II	2012-11-15
K113728	Surfuse Gel and Putty, Exfuse Gel and Putty	Hans Biomed Corp.	MBP	Class II	2012-11-15
K113380	Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator	Medtronic, Inc.	GEI	Class II	2012-11-15