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 1379 of 3531

510(k) clearances, page 1379 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041916	Aloka Ssd-Alpha 5 Ultrasound System	Aloka Co. Ltd USA	IYN	Class II	2004-07-30
K041828	Apex Medical CPAP Model 9S-003	Apex Medical, Inc.	BZD	Class II	2004-07-30
K041707	Cercon Ceram Express Ceramic System	Dentsply Intl.	EIH	Class II	2004-07-30
K041700	Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear	Cantor & Nissel, Ltd.	LPL	Class II	2004-07-30
K041559	55Cm Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #Rs50sh55,rs50nh55,re50sh55 & Re50nh55	Spire Biomedical, Inc.	MSD	Class II	2004-07-30
K041484	Undecided	Siemens Medical Solutions USA, Inc.	LLZ	Class II	2004-07-30
K041469	Anterior Compact System	Xtant Medical Holdings, Inc.	KWQ	Class II	2004-07-30
K041355	Humeral Staple	Smith & Nephew, Inc.	HTY	Class II	2004-07-30
K041352	Compress Distal Femoral Replacement System	Zimmer GmbH	KRO	Class II	2004-07-30
K041157	Modification to Small Bone Fixation System	Hand Innovations, Inc.	HTY	Class II	2004-07-30
K040686	M'ath Std	Intelligence in Medical Technologies	LLZ	Class II	2004-07-30
K033655	Soflex Soft K (Xylofilcon a) Soft (Hydrophilic) Keratoconus Contact Lens for Daily Wear	Soflex Contact Lens Industries, Ltd.	LPL	Class II	2004-07-30
K032239	Thera-Cream, Model Tct004	Prizm Medical, Inc.	GYB	Class II	2004-07-30
K041955	Gemini Pet/ct Imaging System	Philips North America LLC	KPS	Class II	2004-07-29
K041815	Lncs Oximetry Sensors	Masimo Corporation	DQA	Class II	2004-07-29
K041664	Portable Oxygen Generation System: Pogs 33C	On Site Gas Systems Inc.	CAW	Class II	2004-07-29
K041644	Flexi-Stat Disposable Non-Adhesive Spo2 Sensors, (Nellcor-Compatible), (Bci-Compatible), (Datex-Compatible)	Elekon Industries U.S.A., Inc.	DQA	Class II	2004-07-29
K041368	Dentium Co., Ltd. Implantium	Dentium Co., Ltd.	DZE	Class II	2004-07-29
K041223	Modification to Servo-I Ventilator System, Model 64 87 800 E407e	Maquet Critical Care AB	CBK	Class II	2004-07-29
K041128	Suture Arrow	Linvatec Corporation	MAI	Class II	2004-07-29
K041044	Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set	Cook Inc.	JOH	Class II	2004-07-29
K040992	15F X 55Cm Excell Split -Tip Catheter, Models 10300606, 10300706	Medcomp	MSD	Class II	2004-07-29
K033614	Mistic Humidification System 850-00/01/02, 2215	Northgate Technologies Inc.	HIF	Class II	2004-07-29
K031858	Neuro-Endoscope System by Hopf, Existing of: Endoscopes, Sheaths, Working Elements, Bipolar and Unipolar Electrodes	Richard Wolf Medical Instruments Corp.	GWG	Class II	2004-07-29
K031397	Merlin E-Mask	Merlin Medical Limited	CBP	Class II	2004-07-29
K041922	Ge Tethered Portable Digital Radiographic Detector	General Electric Co.	IZL	Class II	2004-07-28
K041772	Datex-Ohmeda Prestn.01 Module (Model Family M-Prestn.01) and Accessories	GE Healthcare	MHX	Class II	2004-07-28
K041410	Punctur-Guard Winged Set for Blood Collection, Model 5118	Abbott Medical	FPA	Class II	2004-07-28
K041399	Hypodermic Needle-Pro Edge Needle Protection Device	Abbott Medical	FMI	Class II	2004-07-28
K041340	Guidant Microwave Ablation System	Guidant Corporation, Cardiac Surgery	NEY	Class II	2004-07-28
K041274	Resorbable Interference Screw	Arthrotek, Inc.	HWC	Class II	2004-07-28
K041233	Arthrojet Xt	Hydrocision, Inc.	HRX	Class II	2004-07-28
K041105	Macropore Hydrosorb Spine System	Macropore Biosurgery, Inc.	KWQ	Class II	2004-07-28
K040682	Synthetic Vinyl Patient Examination Gloves-Powder Free	Grand Work Plastic Products Co., Ltd.	LYZ	Class I	2004-07-28
K040417	Pillar Palatal Implant System	Restore Medical, Inc.	LRK	Class II	2004-07-28
K040031	Ceragem-C Thermal Acupressure Massager	Ceragem Co., Ltd.	JFB	Class II	2004-07-28
K033930	Kapp Custom Ulnar Head Wrist Implant	Kapp Surgical GmbH	KXE	Class II	2004-07-28
K033463	Edwards Lifesciences Research Medical Pediatric Arterial Cannulae	Edwards Lifesciences LLC	DWF	Class II	2004-07-28
K033313	Quatro M Femoral Component	Whiteside Biomechanics, Inc.	LWJ	Class II	2004-07-28
DEN040008	Cedia Sirolimus Assay	Microgenics Corporation	NRP	Class II	2004-07-28
K041870	N Apolipoprotein Standard Serum	Siemens Healthcare Diagnostics Inc.	JIX	Class II	2004-07-27
K041812	Modification to Roche Diagnostics Precinorm Proteins in Urine/csf (Puc) and Precipath Proteins in Urine/csf (Puc)	Roche Diagnostics GmbH	JJY	Class I	2004-07-27
K041682	Caas Mrv	PIE Medical Imaging B.V.	LLZ	Class II	2004-07-27
K041600	Qwikcheck-Beads	Medical Electronics Systems, Ltd.	NRF	Class II	2004-07-27
K041599	Cobra Adhere Surgical System	Estech, Inc.	GEI	Class II	2004-07-27
K041534	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Susceptibility Plate and Susceptibility Test Panel	Trek Diagnostic Systems, Ltd.	JWY	Class II	2004-07-27
K041363	Aoc Bone Wax	Ceremed, Inc.	MTJ	Unclassified	2004-07-27
K041328	Smith & Nephew Electroblade Resector/adaptor	Smith & Nephew, Inc.	GEI	Class II	2004-07-27
K041326	Medcommons Open Radiology Gateway	Medcommons, Inc.	LLZ	Class II	2004-07-27
K041162	Ortho-Cms	Medis Medical Imaging Systems, B.V.	LLZ	Class II	2004-07-27