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 1385 of 3531

510(k) clearances, page 1385 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K033402	Portable Sleep Data Recorder (Psdr)	Pro-Tech Services, Inc.	MNR	Class II	2004-06-30
K033355	Lactoscrew Screw Anchor	Biomet Orthopedics, Inc.	HWC	Class II	2004-06-30
K033174	Bmls03-3	BioMedical Life Systems Inc.	IPF	Class II	2004-06-30
K032438	Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush Syringe	Tyco Healthcare	NGT	Class II	2004-06-30
K041580	Imagerayi	Henry Schein, Inc.	MUH	Class II	2004-06-29
K041471	G-Bond	GC America Inc.	KLE	Class II	2004-06-29
K041204	Nc Sp02 Adapter Cable	Masimo Corporation	DQA	Class II	2004-06-29
K040952	Prelude	Danville Materials, Inc.	KLE	Class II	2004-06-29
K041457	Liquichek Hematology Control (a)	Bio-Rad	JPK	Class II	2004-06-28
K041308	Remotenurse Patient Monitoring System	Webvmc, LLC	DXH	Class II	2004-06-28
K041026	Ambu Blue Sensor, Mrx, ECG Electrode Product #:Mrx-00-S	Ambu, Inc.	DRX	Class II	2004-06-28
K040898	Cellsearch Epithelial Cell Control Kit	Veridex, LLC	NRS	Class II	2004-06-28
K040511	Scd Express Portable Compression System	Tyco Healthcare/Kendall	JOW	Class II	2004-06-28
K033118	Bipro Model Sds-Cb200	Medical Solutions International, Inc.	FIN	Class II	2004-06-28
K041577	Pinnacle3 Radiation Therapy Planning System	Philips North America LLC	LNH	Class II	2004-06-25
K041557	Mobilemosfet Wireless Dosimetry System, Model Tn-Rd-70-W	Thomson & Nielsen Electronics, Ltd.	IYE	Class II	2004-06-25
K041440	Opus Magnum Anchor with Inserter	Opus Medical, Inc.	MBI	Class II	2004-06-25
K041425	Conserve Plus Revision Shell and Conserve Plus Thick Shell	Wrightmedicaltechnologyinc	KWA	Class III	2004-06-25
K041398	Gc Fusion	GC America Inc.	ELW	Class II	2004-06-25
K041332	Joey Clamp Opening Tool	Maternus, Inc.	HFW	Class II	2004-06-25
K041191	Colleague Volumetric Infusion Pumps	Baxter Healthcare Corporation	FRN	Class II	2004-06-25
K041077	Imalux Oct Probe Guide	Imalux Corporation	KKX	Class II	2004-06-25
K041017	Spsmedical Airview Bowie Dick Test Pack	Spsmedical Supply Corp.	JOJ	Class II	2004-06-25
K041009	Raichem Calcium (Ocpc) Liquid Reagent	Hemagen Diagnostics, Inc.	CIC	Class II	2004-06-25
K040908	Ebi Distal Radius Plating System	Ebi, LLC	HRS	Class II	2004-06-25
K040885	Quanta Lite Gp210 Elisa	Inova Diagnostics, Inc.	NRI	Class II	2004-06-25
K040800	Wilosn-Cook Biliary Dilation Balloon	Wilson-Cook Medical Inc.	FGE	Class II	2004-06-25
K040687	Onedose Patient Dosimetry System	Sicel Technologies, Inc.	IYE	Class II	2004-06-25
K040530	Media Culture System	<Genx> Intl., Inc.	MQL	Class II	2004-06-25
K040437	Triage Profiler S.o.b. Panel	Biosite Incorporated	DAP	Class II	2004-06-25
K040241	N-Geneous Wide Range Crp Reagent and Calibrator Set	Genzyme Corporation	DCK	Class II	2004-06-25
K033776	Instead Intimate Lubricant	Instead, Inc.	NUC	Class II	2004-06-25
K032948	Elastic Skin Liquid Bandage	Medpak, LLC	KMF	Class I	2004-06-25
DEN040004	Celleration Mist Therapy System	Celleration, Inc.	NRB	Class II	2004-06-25
K041597	Monochrome Lcd Monitor, Model Radiforce G22	Eizo Nanao Corporation	LLZ	Class II	2004-06-24
K041452	Modification to Verte-Stack Spinal System	Medtronic Sofamor Danek	MQP	Class II	2004-06-24
K041372	Smartlite Ps Pen-Style LED Curing Light	Dentsply International, Inc.	EBZ	Class II	2004-06-24
K041370	Lifestent Lp Sds Biliary Endoprosthesis	Orbusneich Medical, Inc.	FGE	Class II	2004-06-24
K041280	Human Subcutaneous Injector, Model Hsi 500	Felton International, Inc.	KZE	Class II	2004-06-24
K040850	Tsy Shoulder Plate Implant	Orthopedic Sciences, Inc	HRS	Class II	2004-06-24
K040063	Inspektor Pro	Inspektor Dental Care BV	NBL	Class II	2004-06-24
K034053	Tms Snapp Soft Nasal Accessory for Positive Pressure, Models Tms-3020, Tms-3030 & Tms-3040	Tiara Medical Systems, Inc.	BZD	Class II	2004-06-24
K033533	Powder Free Latex Examination Gloves	Apl International Incorporated Limited	LYY	Class I	2004-06-24
K033303	Wafer System	Spine Wave Inc	HRS	Class II	2004-06-24
K031939	Bio-Eurolig Interference Screw	Fournitures Hospitalieres Industrie	HWC	Class II	2004-06-24
K041590	Autodetect Syringe	Indigo Orb, Inc.	FMF	Class II	2004-06-23
K041546	Digital Fundus Camera, Model Cf-60Dsi	Canon, Inc.	HKI	Class II	2004-06-23
K040953	Aeskulisa Ana Hep-2	Aesku, Inc.	LJM	Class II	2004-06-23
K040494	Capsule Delivery Device, 160Cm, Model 711143; Capsule Delivery Device, 210Cm, Model 711144	United States Endoscopy Group, Inc.	NEZ	Class II	2004-06-23
K040474	Accusoft	Direx Systems Corp.	MUJ	Class II	2004-06-23