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 1419 of 3531

510(k) clearances, page 1419 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032563	Clinitest Hcg Pregnancy Test	Medrad, Inc.	JHI	Class II	2003-12-23
K032417	Heparin Lock Flush Syringe	Am2 Pat, Inc.	FOZ	Class II	2003-12-23
K032113	Acis (Automated Cellular Imaging System)	Chroma Vision Medical Systems, Inc.	NOT	Class II	2003-12-23
K032061	Decathlon Twin Lumen Hemodialysis with Separated Tips, Models De19/24sh, De23/28sh, De27/32sh, De 31/36Sh, De19/24nh	Spire Biomedical, Inc.	MSD	Class II	2003-12-23
K031689	Dual Lumen Extended Length Catheter (Delc)	Chf Solutions, Inc.	NQJ	Class II	2003-12-23
K031322	Intra-Lock Hydroxyapatite Coated Implants	Intra-Lock International	DZE	Class II	2003-12-23
K031281	Ergo Srs	3D Line USA, Inc.	MUJ	Class II	2003-12-23
K031267	Sterichek Bicarb Ph Reagent Strips	Environmental Test Systems, Inc.	MNV	Class II	2003-12-23
K030360	Randox Evidence	Randox Laboratories, Limited	DIO	Class II	2003-12-23
K033799	Clinical Lasette P-200	Cell Robotics, Inc.	GEX	Class II	2003-12-22
K033629	Versyo.bond	Kulzer GmbH	EBI	Class II	2003-12-22
K033528	Mesacup-2 Test Jo-1, Model 10756	Rhigene, Inc.	LLL	Class II	2003-12-22
K033394	Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System	Cordis US Corp.	FGE	Class II	2003-12-22
K033308	Vinyl Examination Gloves, Powdered	Tangshan Transocean Plastic Products Co., Ltd.	LYZ	Class I	2003-12-22
K033267	Epricord	Kuraray Medical, Inc.	EBF	Class II	2003-12-22
K033192	Rh-950	Iomed, Inc.	KTB	Class II	2003-12-22
K032925	B&r Device	Ronvig A/S	EGS	Class I	2003-12-22
K031968	Cerabien Zr	Noritake Co., Inc.	EIH	Class II	2003-12-22
K030871	Fidji Large Cement Restrictor	Spine Next SA	JDK	Class II	2003-12-22
K030767	Fidji Small Cement Restrictor	Spine Next SA	JDK	Class II	2003-12-22
K033867	Ge Brainwave Option(s) for MRI Systems	General Electric Co.	LNH	Class II	2003-12-19
K033857	T-Tech Digital, Model Wl-22Xxa Series	Well-Life Healthcare Limited	GZJ	Class II	2003-12-19
K033831	Sienet Cosmos	Siemens AG Medical Solutions	LLZ	Class II	2003-12-19
K033795	Plasmacure Bxe	Eele Laboratories, LLC	EBZ	Class II	2003-12-19
K033782	Allegro Imaging System	Philips North America LLC	KPS	Class II	2003-12-19
K033758	Hydrophilic Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2003-12-19
K033691	Safyre Vs and Safyre T	Promedon	OTN	Class II	2003-12-19
K033657	Mobile External Counter Pulsation System Angionew-V	Living Data Technologies Corporation	DRN	Class II	2003-12-19
K033603	Instrinsic Factor Ab, Calibrators, and Qc on the Access Immunoassay Systems, Models 387992, 387993, 387999	Siemens Healthcare Diagnostics Inc.	LIG	Class II	2003-12-19
K033558	Bd Phoenix Automated Microbiology System - Aztreonam 0.5-64 Ug/ml-Gram-Negative Id/ast or Ast Only Phoenix Panels	Becton Dickinson & Co	LON	Class II	2003-12-19
K033379	Bayer Special Chemistry Controls	Bayer Diagnostics Corp.	JJY	Class I	2003-12-19
K033359	Degall II Gallbladder Extractor	Surgicon AG	GCJ	Class II	2003-12-19
K033287	Exactrac Gating	Brainlab, Inc.	IYE	Class II	2003-12-19
K033280	Discovery Elbow-Mosaic Distal Humeral Replacement System	Zimmer GmbH	JDC	Class II	2003-12-19
K033203	Wilson-Cook Tri-Tome Select Plus	Wilson-Cook Medical Inc.	KNS	Class II	2003-12-19
K033159	Lemaitre Vascular Straight Carotid Shunt, Model 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05	LeMaitre Vascular Inc.	MJN	Class II	2003-12-19
K033094	Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)	Lin-Zhi International Inc	DKZ	Class II	2003-12-19
K033084	Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter	Abbott Medical	MQF	Class II	2003-12-19
K033076	Lifestyles Liquid Personal Lubricant	Ansell Healthcare Products LLC	HIS	Class II	2003-12-19
K033020	Impak Acrylic Repair Resin Liquid	Cmp Industries, LLC	EBI	Class II	2003-12-19
K032950	Gem Inset Patellar Component	Kinamed Inc	JWH	Class II	2003-12-19
K032944	Ya-Man Laser 21	YA-Man Ltd.	GEX	Class II	2003-12-19
K032928	Mediphysics Pain Treatment System, Model 1	Mediphysics Pain Centers of America	GZJ	Class II	2003-12-19
K032893	Shelhigh No-React Biocuff	Shelhigh, Inc.	FTL	Class II	2003-12-19
K032887	Phenol Red Stock Solution	FUJIFILM Biosciences Inc.	MQL	Class II	2003-12-19
K032763	Vascular Solutions Pronto Extraction Catheter	Vascular Solutions LLC	QEZ	Class II	2003-12-19
K032663	Quantex Crp High Sensitivity Standard Multipoint, Quantex Crp High Sensitivity Controls Ve Controls 1/2	Instrumentation Laboratory Co.	DCK	Class II	2003-12-19
K032288	Vitoss Scaffold Foam Bone Graft Material	DSM Biomedical, Inc.	MQV	Class II	2003-12-19
K032251	Immunetech Total Ige System	Immunetech Corporation	DGC	Class II	2003-12-19
K032219	Revolution Spinal Fixation System	Spinal Innovations, LLC	MNI	Class II	2003-12-19