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 1093 of 3531

510(k) clearances, page 1093 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K090453	Silver Alginate 11 Wound Dressing	Advanced Medical Solutions Limited	FRO	Unclassified	2009-02-26
K090294	Fora Ir22 Ear Thermometer, Model Td-1262	Taidoc Technology Corporation	FLL	Class II	2009-02-26
K090260	Modification To:straumann Guided Instruments	Straumann USA, LLC	DZE	Class II	2009-02-26
K090097	Lh-75T Phototherapy System	Lerner Medical Devices, Inc.	FTC	Class II	2009-02-26
K083654	Zimmer Universal Locking System 2.7 Mm Locking Plates and Screws ( Tivanium Ti-6A1-4V Alloy, Cp Grade Titanium)	Zimmer GmbH	HRS	Class II	2009-02-26
K083550	Straumann Dental Implant System	Straumann USA, LLC	DZE	Class II	2009-02-26
K083424	Busse Surgical Drape	Busse Hosipital Disposables	KKX	Class II	2009-02-26
K083103	Acryderm Antimicrobial Silver Gel Wound Dressing Model #B	Acrymed, Inc.	FRO	Unclassified	2009-02-26
K082638	Advia Centaur System with Streamlab Analytical Workcell	Siemens Healthcare Diagnostics Inc.	KLI	Class II	2009-02-26
K082296	Copa Amd	Covidien Lp, Formerly Registered AS Tyco Healthcar	FRO	Unclassified	2009-02-26
K082057	Dx6605e-TENS, Dx6605e-G, Dx6609-G	Shenzhen Dongdixin Technology Co., Ltd.	GZJ	Class II	2009-02-26
K081532	Pharmajet Needle-Free Injection System	Pharmajet, Inc.	KZE	Class II	2009-02-26
K083732	Tad and Tad II Tapered Guide Wires	Abbott Vascular	DQX	Class II	2009-02-25
K083691	Bonevue	Micromri, Inc.	LLZ	Class II	2009-02-25
K083683	Ats Simulus Semi-Rigid Mitral Annuloplasty Ring, Model 800Sc	Genesee BioMedical, Inc.	KRH	Class II	2009-02-25
K083663	Pacp	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWQ	Class II	2009-02-25
K083375	Renasys Go Negative Pressure Wound Therapy	Smith & Nephew, Inc.	OMP	Class II	2009-02-25
K083324	Locator Implant Anchor Attachment System	Zest Anchors LLC	NHA	Class II	2009-02-25
K083281	El Lightwave Suction Ablator, Model El-2000-S, Lightwave Suction Ablator, Model Ia-2000-S, Lightwave Ablator, Model Ia-	Linvatec Corporation	GEI	Class II	2009-02-25
K082836	ICU Medical Universal Single-Use Spikes	Abbott Medical	FMG	Class II	2009-02-25
K082623	Visix Imaging	Televere Systems	LLZ	Class II	2009-02-25
K082583	Intellivue Patient Monitor, Intellibridge Module, Models Mp40, Mp50, Mp60, Mp70, Mp80, Mp90, Ec10, Ec5	Philips Medizinsysteme Boeblingen GmbH, Cardiac an	MHX	Class II	2009-02-25
K082498	Graftys Hbs	Graftys	MQV	Class II	2009-02-25
K082480	Contec Pocket Fetal Doppler	Contec Medical System Co., Ltd.	KNG	Class II	2009-02-25
K082404	Navigation Probes	We Sense, Ltd.	GZL	Class II	2009-02-25
DEN070002	Qmt Nimbus Antimicrobial Barrier Gauze Dressing	Quick-Med Technologies, Inc.	NYS	Class II	2009-02-25
K083645	Radstar Family, Models: Radstar 4343 & Variations	5 Star Medical, Inc.	MQB	Class II	2009-02-24
K083541	Neonate Head and Body Coils	Advanced Imaging Research, Inc.	MOS	Class II	2009-02-24
K082286	Bioactys	Graftys	LYC	Class II	2009-02-24
K090378	Chromophare E 668	Berchtold GmbH & Co. KG	FSY	Class II	2009-02-23
K083879	Innocor Ergospirometry System (Inn00010), the Basic Innocor Including Breath-by-Breath System (Inn00400), Nibp(inn00500)	Innovision, Inc.	BZG	Class II	2009-02-23
K083752	Gluseal 90, Model Glu9010	Glustitch, Inc.	KMF	Class I	2009-02-23
K083713	.035 Loc Guide Wire Extension	Abbott Vascular	DQX	Class II	2009-02-23
K083710	Retractor Lite	Thomas Surgical Instruments, Inc.	FST	Class II	2009-02-23
K083641	Bivona Tracheostomy Tubes	Abbott Medical	JOH	Class II	2009-02-23
K083229	E.s Teck ( Electro Sensor Teck)	LD Technology LLC	MWI	Class II	2009-02-23
K083178	Solas Anatomix Spinal System	Biotechni America Spine Group, Inc.	MNI	Class II	2009-02-23
K083101	Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones	Sable Industries, Inc.	EFB	Class I	2009-02-23
K083056	Neo-Stat CO2 <Kg	Mercury Medical	CCK	Class II	2009-02-23
K082693	Resolutionmd, Release 2.1	Calgary Scientific, Inc.	LLZ	Class II	2009-02-23
K081541	Dermablate Effect	Asclepion Laser Technologies GmbH	GEX	Class II	2009-02-23
K080008	Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set	Bio-Rad Laboratories Inc.	OMI	Class II	2009-02-23
K090334	Acuson S2000 Diagnostic Ultrasound System	Siemens Medi Cal Solutions, Inc.	IYN	Class II	2009-02-20
K090242	Gamma-Bsm, Beta-Bsm	Etex Corp.	MQV	Class II	2009-02-20
K090177	Inion Biorestore Biodegradable Bone Graft Substitute	Inion Oy	MQV	Class II	2009-02-20
K090162	Evicel Application Device	Omrix Biopharmaceuticals, Ltd.	FMF	Class II	2009-02-20
K090133	Connex Gastrointestinal Suture Anchor, Model Gias	Cook Inc.	FGE	Class II	2009-02-20
K083786	Corflo Anti-IV Enteral Feeding Extension Set, Models 20-1006Aiv-Lb and 20-1030Aiv-Lb	Halyard Health	FPD	Class II	2009-02-20
K083778	Xenium Xph, Models 110, 130, 150, 170, 190 and 210	Baxter Healthcare Corporation	KDI	Class II	2009-02-20
K083727	Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012	Boston Scientific Corporation	DQX	Class II	2009-02-20