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 1251 of 3531

510(k) clearances, page 1251 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061247	Diasorin Liaison Treponema Assay	Diasorin Inc.	LIP	Class II	2006-07-31
K060966	Cooltouch Varia Nd:yag Laser System	Cooltouch Corp.	GEX	Class II	2006-07-31
K060584	Nc-Stat	Neurometrix, Inc.	JXE	Class II	2006-07-31
K060556	Brigit Surgical Device	Zimmer GmbH	HAW	Class II	2006-07-31
K053654	Atlantis Abutment for Nobel Replace Interface	Atlantis Components, Inc.	NHA	Class II	2006-07-31
K062024	Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin, Theophylline Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	LFM	Class II	2006-07-28
K061952	Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16	Invivo Corporation	MOS	Class II	2006-07-28
K061930	Indomitable Magnetic Resonance Imaging Scanner Accessory	Fonar Corp.	LNH	Class II	2006-07-28
K061913	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	LHN	Class II	2006-07-28
K061803	Sta - Control La 1+2	Diagnostica Stago, Inc.	GGC	Class II	2006-07-28
K061758	Active Renin Irma	Diagnostic Systems Laboratories, Inc.	CIB	Class II	2006-07-28
K061715	Mrgfus General Purpose and Breast Coil	Insightec Txsonics, Inc.	MOS	Class II	2006-07-28
K061673	Bd Phoenix Automated Microbiology System-Amoxicillin-Clavulanate(gp) 0.25/0.12 -32/16 Ug/ml	Becton Dickinson & Co	LON	Class II	2006-07-28
K061580	Eclipse Wax Remover	Dentsply International, Inc.	EBI	Class II	2006-07-28
K061561	Hip Structural Analysis Software Option for the Hologic Qdr X-Ray Bone Densitometers	Hologic, Inc.	KGI	Class II	2006-07-28
K061368	Diagnosoft Harp	Diagnosoft, Inc.	LNH	Class II	2006-07-28
K061241	Biolucent Applicator, Model Rta-Xx	Biolucent, Inc.	JAQ	Class II	2006-07-28
K061102	Prima Anaesthesia Machine	Penlon, Ltd.	BSZ	Class II	2006-07-28
K061094	Newport E500 Wave Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2006-07-28
K060983	Biopsy Medium, Model Ref 1062	Medicult A/S	MQL	Class II	2006-07-28
K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	IYE	Class II	2006-07-28
K060354	Acro Biotech Llc Rapid Benzodiazepine Urine Test, Catalog Bzd001000	ACRO BIOTECH Inc.	JXM	Class II	2006-07-28
K060320	Femecc Endocervical Curette	Femspec LLC	PCF	Class II	2006-07-28
K061964	Syngo Multimodality Workplace	Siemens AG Medical Solutions	LLZ	Class II	2006-07-27
K061865	Flex 10 Mis Ablation Probe, Model Flx10mi-05	Boston Scientific Corporation	NEY	Class II	2006-07-27
K061854	Xia Titanium Spinal System and Xia Stainless Steel Spinal System	Howmedica Osteonics Corp	NKB	Class II	2006-07-27
K061643	Echo View/shimasonic Diagnostic Ultrasound System, Model Sdu-1200Pro	Shimadzu Medical Systems	IYN	Class II	2006-07-27
K061640	Integra Mobius Multi-Modality Monitoring System	Integra LifeSciences Corporation	GWM	Class II	2006-07-27
K061621	Synthes (USA) 6.5 Mm Cancellous Screws	Synthes (USA) Products LLC	HWC	Class II	2006-07-27
K061423	M2a Magnum 12/14 Taper Inserts and One-Piece Modular Heads	Biomet Manufacturing Corp	KWA	Class III	2006-07-27
K061220	Urgotul Ag	Laboratoires Urgo	FRO	Unclassified	2006-07-27
K061204	Masimo Set Radical 7 Pulse Co-Oximeter	Masimo Corporation	DQA	Class II	2006-07-27
K061180	Ksea Rotocut G1 Electromechanical Morcellator	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	2006-07-27
K060187	Topslane Dmlc	Topslane International, LLC	IXI	Class II	2006-07-27
K052957	Implantium Prosthetics	Dentium Co., Ltd.	NHA	Class II	2006-07-27
K061784	Insorb Absorbable Staple, Model 1020	Incisive Surgical, Inc.	GDW	Class II	2006-07-26
K061620	Ifs Cannulated Bone Screw	Internal Fixation Systems, Inc.	HWC	Class II	2006-07-26
K061599	Pin Screw	BK Meditech Co., Ltd.	JDW	Class II	2006-07-26
K061501	Flexo Dental Resin Material	Aci, Inc.	EBI	Class II	2006-07-26
K061482	Altes Buttress Plating System	Altiva Corp.	KWQ	Class II	2006-07-26
K061476	Electro-Nerve Stimulator TENS, Model Bmls06-1	BioMedical Life Systems Inc.	GZJ	Class II	2006-07-26
K061285	Smartsite Needle Free Valve Administration Sets	Cardinal Health, Alaris Products	FPA	Class II	2006-07-26
K061162	Bar Pedicle Screw Spinal Fixation System, Model 2020	Applied Spine Technologies, Inc.	MNH	Class II	2006-07-26
K060973	Vycor Surgical Access Systems	Vycor Medical, Inc.	GZT	Class II	2006-07-26
K060471	Fssb Nylon Surgical Sutures	Fssb Chirurgische Nadeln GmbH	GAR	Class II	2006-07-26
K060018	Trulene Mesh	Sutures India Pvt., Ltd.	FTL	Class II	2006-07-26
K051595	Tso3 Ozone Sterilizer, Model 125L	Tso3, Inc.	FLF	Class II	2006-07-26
K061962	Surgi-Cuf Reusable, Rs Series	Salter Labs	DXQ	Class II	2006-07-25
K061947	21.3 Inch Monochrome Lcd Monitor	Nec Display Solutions, Ltd.	LLZ	Class II	2006-07-25
K061915	Cd Horizon Spinal System	Medtronic Sofamor Danek	MNH	Class II	2006-07-25