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 1262 of 3531

510(k) clearances, page 1262 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K061095	Auto Sutur Endo Gia Staplers	United States Surgical, A Division of Tyco Healthc	GDW	Class II	2006-05-31
K061025	Accutech Endolite Probe	Accutech Medical Technologies, Inc.	FFS	Class II	2006-05-31
K060905	Iridex Otoprobe Long and Short Angles, P/n 14310-1 and 14320-1	Iridex Corporation	GEX	Class II	2006-05-31
K060707	Aesculap Bipolar Acetabular Cup	Aesculap Inc	KWY	Class II	2006-05-31
K060407	Juniper Cooling Device	Juniper Medical Technology, Inc.	GEX	Class II	2006-05-31
K060352	Health Line International Corporations,s IV Administrative Sets	Health Line International Corporation	FPA	Class II	2006-05-31
K060200	Microtek Medical Warming Drape	Microtek Medical LLC	KKX	Class II	2006-05-31
K060172	Rema Shaver Blades	Rema Medizintechnik GmbH.	HRX	Class II	2006-05-31
K053629	Anchor Plus/neo Anchor Plus	KJ Meditech Co., Ltd.	DZE	Class II	2006-05-31
K051104	Eye See Multipurpose, No-Rub Contact Lens Solution	Lapis Lazuli, NV	LPN	Class II	2006-05-31
K061396	Qlab Quantification Software	Philips North America LLC	LLZ	Class II	2006-05-30
K061372	Centricity Aw Suite Option	GE Healthcare Information Technologies	LLZ	Class II	2006-05-30
K061370	Cardiq Fusion	GE Healthcare	JAK	Class II	2006-05-30
K061201	Dsnare Diminutive Polypectomy and Suction System, Model 00711087	United States Endoscopy Group, Inc.	FCK	Class II	2006-05-30
K061196	Cardioimmune Xl Cardiac Marker Control	Microgenics Corporation	JJY	Class I	2006-05-30
K060922	Oxlife Freedom Five Oxygen Concentrators, Model Kxf5	Oxlife, Inc.	CAW	Class II	2006-05-30
K060850	Nod Chemistry Control	Bioresource Technology	JJY	Class I	2006-05-30
K060692	Comprehensive Primary Shoulder Stems	Biomet Manufacturing Corp	MBF	Class II	2006-05-30
K060645	Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus Calibrators	Roche Diagnostics GmbH	DKB	Class II	2006-05-30
K060561	Clearadex Gel	Cambridgemed	KHJ	Class II	2006-05-30
K060539	Dpoae20 , Eclipse	Interacoustics A/S, Assens	EWO	Class II	2006-05-30
K060449	Hi-Torque Advance and Advance Lite Guide Wire	Boston Scientific Corporation	DQX	Class II	2006-05-30
K060374	Refa, Physiological Amplifier	Tms International BV	GWL	Class II	2006-05-30
K060258	Autofuser	Ace Medical Us, LLC	MEB	Class II	2006-05-30
K060189	Pediatric Subdermal Wire Electrode (Pswe)	Ives EEG Solutions	GXZ	Class II	2006-05-30
K053363	Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes, Intraoperative Subdural Electrodes	AD-Tech Medical Instrument Corp.	GYC	Class II	2006-05-30
K061228	Full Breath Sleep Appliance with Posterior Tongue Depressor	Bryan Keropian Dds	LQZ	Class II	2006-05-26
K061052	The Philips Intellivue Patient Monitors, Models Mp20,mp30,mp40,mp50,mp60,mp70,mp80,mp90	Philips North America LLC	MHX	Class II	2006-05-26
K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head	Aesculap Inc	LZO	Class II	2006-05-26
K060735	Drx9000 True Spinal Decompression System	Axiom Worldwide, Inc.	ITH	Class II	2006-05-26
K060722	Nexgen Complete Knee Solution Ultracongruent (Uc-Flex) Fixed Bearing Articular Surface Component	Zimmer GmbH	JWH	Class II	2006-05-26
K060546	Breas Vivo Bilevel System, Model Vivo 30	Breas Medical AB	MNS	Class II	2006-05-26
K053382	Laparo-Thoraco Videoscope Xltf-Vaw	Olympus Medical Systems Corp.	GCJ	Class II	2006-05-26
K052271	Rinsendo	Air Techniques, Inc.	NYL	Class I	2006-05-26
K061330	Psl Portable Slit Lamp	Reichert, Inc.	HJO	Class II	2006-05-25
K061326	Voxar 3D Enterprise with Cardiametrix	Barcoview Mis Edinburgh	LLZ	Class II	2006-05-25
K061305	Medical Display, Mdc1900-1Lg (1Lr)	Chi Lin Technology Co., Ltd.	LLZ	Class II	2006-05-25
K061303	Medical Display, Models Mdm 1900-1Ng and Mdm 1900-1Nr	Chi Lin Technology Co., Ltd.	LLZ	Class II	2006-05-25
K061295	Versaclear Skin Therapy System, Model 100	Theralight, LLC	FTC	Class II	2006-05-25
K061274	Venture Anterior Cervical Plate System	Medtronic Sofamor Danek	KWQ	Class II	2006-05-25
K061238	Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge	Siemens Healthcare Diagnostics Inc.	KHS	Class II	2006-05-25
K061182	Cliniqa Liquid Qc Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus Au Systems;qalib	Cliniqa Corporation	JJY	Class I	2006-05-25
K061170	3.0T Pediatric Head and Spine Array, Model 808Ge3000	Resonance Innovations, LLC	MOS	Class II	2006-05-25
K061067	Trabecular Metal Acetabular Augments	Zimmer Trabecular	LPH	Class II	2006-05-25
K061059	Modified Merci Retriever, Model 90092	Concentric Medical, Inc.	NRY	Class II	2006-05-25
K060964	Architect Bnp Assay, Model 8K28	Fujirebio Diagnostics, Inc.	NBC	Class II	2006-05-25
K060893	Modification to Rebilda Dc	Voco GmbH	EBF	Class II	2006-05-25
K060811	Omron Compressor Systems, Models Ne-C28,ne-C30	Omron Healthcare Co., Ltd.	CAF	Class II	2006-05-25
K060790	Breas, Model Ha01	Breas Medical AB	BTT	Class II	2006-05-25
K060776	Surgical Face Mask	Hong YA Non-Woven Products Co., Ltd.	FXX	Class II	2006-05-25