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 2026-11-02, 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 967 of 3531

510(k) clearances, page 967 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110436	Fdi Glucose Control Solution for Aviva	Fujirebio Diagnostics, Inc.	JJX	Class I	2011-04-20
K110210	Saturn 8000-Gs	New Medical Co., Ltd.	MQB	Class II	2011-04-20
K110112	Cell-Tissue Converter (Ctc) Syringe with Needle	Rongshan LI	FMF	Class II	2011-04-20
K103833	Neopip Patient Circuit with PEEP	Neoforce Group, Inc.	BYE	Class II	2011-04-20
K103317	Resuscitation Unit 105	Atom Medical Corporation	BZR	Class II	2011-04-20
K102859	Retcam 3 Opthalmic Imaging System	Clarity Medical Systems	HKI	Class II	2011-04-20
K102804	Spi Titanium Base for Cad/cam	Thommen Medical AG	NHA	Class II	2011-04-20
K101827	Osteoscaf	Texas Innovative Medical Devices (dba) Skeletal	LYC	Class II	2011-04-20
K110816	Parietex Optimized Composite Mesh (Pco-Osx References)	Sofradim Production	FTL	Class II	2011-04-19
K110815	Parietex Optimized Compostie Mesh	Sofradim Production	FTL	Class II	2011-04-19
K110779	Spacelabs Smart Disclosure System	GE Healthcare	DQK	Class II	2011-04-19
K110521	Everon Central Display Station (Cds)	Earlysense, Ltd.	MSX	Class II	2011-04-19
K110487	Flexible Cardiac Coil	Lbds Holding Company	MOS	Class II	2011-04-19
K110434	Trixel CO2 Laser	Beijing Syntech Laser Co., Ltd	GEX	Class II	2011-04-19
K110338	Powder-Free Vinyl Patient Examination Gloves	Zibo Yuechuan Plastic Products Co., Ltd.	LYZ	Class I	2011-04-19
K110219	Powder Free Vinyl Patient Examination Gloves	Wealth on (Jiangsu) Co., Ltd.	LYZ	Class I	2011-04-19
K110148	Wexler Vascular Clamp Series	Microsurgical Laboratories,Inc.Dba Wexler Surgical	DXC	Class II	2011-04-19
K110029	Conserve Bio Foam Shell	Wrightmedicaltechnologyinc	KWA	Class III	2011-04-19
K103277	3M Attest 1491 Super Rapid Readout Biological Indicator; 3M Attest 490 Auto-Reader	3M Company-3M Health Care	FRC	Class II	2011-04-19
K102480	Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (Pzd) Pipette; Assisted Ha	Jieying Laboratory, Inc.	MQH	Class II	2011-04-19
K102034	Blue Sky Bio Dental Implant System	Blue Sky Bio, LLC	DZE	Class II	2011-04-19
K093581	Discovery Model Ct590 Rt and Optima Model Ct580 CT Systems	GE Healthcare	JAK	Class II	2011-04-19
K090277	Natus Sleepworks, Model 104017	Excel-Tech Ltd. (Xltek)	OLZ	Class II	2011-04-19
DEN110012	Aptima Trichomonas Vaginalis Assay	Gen-Probe Incorporated	OUY	Class II	2011-04-19
K110136	Respichamber Valved Holding Chamber	Trudell Medical Intl.	NVP	Class II	2011-04-18
K103729	Infill Intervertebral Body Fusion Device	Pinnacle Spine Group, LLC	MAX	Class II	2011-04-18
K103362	Aoi Cranial Helmet	Advanced Orthopro, Inc.	MVA	Class II	2011-04-18
K100344	Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and Kc605	Siemens Healthcare Diagnostics Inc.	MOI	Class II	2011-04-18
K110921	Nitrile Powder-Free Examination Gloves Tested for Use with Chemotherapy Drugs	Medtronic, Inc.	LZA	Class I	2011-04-15
K110841	Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer	Shantou Institute of Ultrasonic Instruments (Siui	IYN	Class II	2011-04-15
K110767	Angiosculpt Pta Scoring Balloon Catheter	Spectranetics Corp.	PNO	Class II	2011-04-15
K110152	Spsmedical Vaporized Hydrogen Peroxide Chemical Indicators	Spsmedical Supply Corp.	JOJ	Class II	2011-04-15
K103662	Continuum and Trilogy Integrated Taper (It) Acetabular Systems; Longevity It Highly Crosslinked Polyethylene Elevated Li	Zimmer GmbH	LPH	Class II	2011-04-15
K103606	Artiste Solution with Sys_vb50 Update	Siemens Medical Solutions USA, Inc.	IYE	Class II	2011-04-15
K103527	Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox	International Biomedical, Ltd.	FPL	Class II	2011-04-15
K103524	Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with Nellcor Pulseox	International Biomedical, Ltd.	FPL	Class II	2011-04-15
K103091	Lanx Spinal Fixation System	Lanx, Inc.	KWP	Class II	2011-04-15
K103042	Atmos E 201 Thorax and Atmos S 201 Thorax	Atmos, Inc.	BTA	Class II	2011-04-15
K102418	Reverse Medical Report Guide Catheter System	Reverse Medical Corporation	DQY	Class II	2011-04-15
K100183	Model Mc-180Ma Multi-Frequency Body Composition Analyzer	Tanita Corp.	MNW	Class II	2011-04-15
K110887	Injection Gold Probe Bipolar Electrohemostasis Catheter	Boston Scientific Corporation	KNS	Class II	2011-04-14
K110705	Apnea Risk Evaluation System (Ares)	Advanced Brain Monitoring, Inc.	MNR	Class II	2011-04-14
K110547	Optertrak Logic Psc Tibial Insert	Exactech Sarasota	JWH	Class II	2011-04-14
K110368	Novabone Putty - Bioactive Synthetic Bone Graft	Novabone Products, LLC	MQV	Class II	2011-04-14
K110319	Evercross 0.035 Otw Pta Dilatation Catheter	Medtronic, Inc.	LIT	Class II	2011-04-14
K110240	Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1	Smith & Nephew, Inc.	OLO	Class II	2011-04-14
K103582	Kelyniam Custom Skull Implant (Csi)	Kelyniam Global, Inc.	GXN	Class II	2011-04-14
K102847	Disposable Endometrial Suction Curette	Jiangsu Suyun Medical Materials Co., Ltd.	HHK	Class II	2011-04-14
K102085	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Shijiazhuang Glory Plastic Co., Ltd.	LYZ	Class I	2011-04-14
K101867	Vicor Pd2i Analyzer	Vicor Technologies, Inc.	DPS	Class II	2011-04-14