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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 617 of 3529

510(k) clearances, page 617 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K160402	GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)	Instrumentation Laboratory Co.	CGA	Class II	2016-12-14
K160225	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator	Instrumentation Laboratory Co.	JGS	Class II	2016-12-14
K163203	Carestream DRX-Evolution	Eastman Kodak Company	KPR	Class II	2016-12-13
K162643	MediGuide Technology System	Abbott Medical	DQK	Class II	2016-12-13
K162010	Hpm-6000U	BTL Industries, Inc	KPI	Class II	2016-12-13
K161844	Matrix Pre-Treatment Controller	Better Water, Inc.	FIP	Class II	2016-12-13
K160941	Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter	BrosMed Medical Co.,Ltd.	LIT	Class II	2016-12-13
K160335	Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D	Abbott Medical	DRF	Class II	2016-12-13
K160306	Cloud Smart Thermometer	Guangzhou Bosma Technology Co, Ltd.	FLL	Class II	2016-12-13
K160218	AutoMark Module	Abbott Medical	DQK	Class II	2016-12-13
K160210	EnSite Precision Cardiac Mapping System v2.0	Abbott Medical	DQK	Class II	2016-12-13
K163373	Pk Aim	Gyrus ACMI, Inc.	GEI	Class II	2016-12-12
K163190	InMode RF System	Inmode MD, Ltd.	GEI	Class II	2016-12-12
K163063	UC-5000 Mobile X-Ray	Source-Ray, Inc.	IZL	Class II	2016-12-12
K162648	U-Blade Veress Needle	Tianjin Uwell Medical Device Manufacturing Co Ltd	HIF	Class II	2016-12-12
K162476	Varian High Energy Linear Accelerator	Varian Medical Systems, Inc.	IYE	Class II	2016-12-12
K162442	ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500	Gri Medical & Electrical Technology Co., Ltd.	FYA	Class II	2016-12-12
K162420	Sysmex Automated Blood Coagulation Analyzer CS-5100	Siemens Healthcare Diagnostics Products Limited	JPA	Class II	2016-12-12
K162327	COUGAR® LS Lateral Cage System and COUGAR® System	Medos International SARL	MAX	Class II	2016-12-12
K162114	Photon, Photon Plus	Zolar Technology & Mfg Co Inc	GEX	Class II	2016-12-12
K160969	ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler	Shinemed, LLC	GDW	Class II	2016-12-12
K160745	neoBLUE compact LED Phototherapy System	Natus Medical Incorporated	LBI	Class II	2016-12-12
K162227	STA® - Liatest® D-Di	Diagnostica Stago, Inc.	DAP	Class II	2016-12-10
K163154	Traxcess 7 Mini XSoft Guidewire	Terumo Cardiovascular Systems Corporation	MOF	Class II	2016-12-09
K162974	Biomet Microfixation RibFix Blu Thoracic Fixation System	Biomet Microfixation	HRS	Class II	2016-12-09
K162869	Contact Lens Case	Ningbo Yinzhou Zonghai Artware Co., Ltd.	LRX	Class II	2016-12-09
K162829	Medline UNITE® Ankle Fracture Plating System	MEDLINE INDUSTRIES, LP - Northfield	HRS	Class II	2016-12-09
K162783	EnFocus 2300, EnFocus 4400	Bioptigen, Inc.	OBO	Class II	2016-12-09
K162623	16ch T/R Hand Wrist Coil	Quality Electrodynamics	MOS	Class II	2016-12-09
K162600	Jewel Precision Reusable Rigid Sterilization Container System	Jewel Precision Sheet Metal & Machine, Inc.	KCT	Class II	2016-12-09
K162516	BD Pen Needle	Becton Dickinson & Co	FMI	Class II	2016-12-09
K162512	truSculpt	Cutera Inc	PBX	Class II	2016-12-09
K162205	Arc EndoCuff and Arc EndoCuff Vision	Boddingtons Plastics, Ltd.	FED	Class II	2016-12-09
K161972	Slit Lamp SL-D301	Topcon Corp.	HJO	Class II	2016-12-09
K161900	Hyperion X5	Cefla S.C.	OAS	Class II	2016-12-09
K161734	Vanguard Dental Unit	Ritter Concept GmbH	EIA	Class I	2016-12-09
K160487	V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System	KCI USA, Inc.	OMP	Class II	2016-12-09
K163078	Dc-Uibc-Cal	Sekisui Diagnostics P.E.I. Inc.	JIT	Class II	2016-12-08
K162912	VIPER PRIME™ additions to the VIPER® System	Medos International SARL	NKB	Class II	2016-12-08
K162747	Proture Double Electric Breast Pump	Guangdong Horigen Mother & Baby Products Co., Ltd.	HGX	Class II	2016-12-08
K162376	CAAS MR 4D Flow	PIE Medical Imaging B.V.	LLZ	Class II	2016-12-08
K162246	ProNova SC360 Proton Therapy System	Pronova Solutions, LLC	LHN	Class II	2016-12-08
K162194	MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System	Medicrea International	KWQ	Class II	2016-12-08
K162005	Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers Inc.	HQD	Class II	2016-12-08
K161827	Reprocessed Response Diagnostic Electrophysiology Catheters	Innovative Health, LLC.	NLH	Class II	2016-12-08
K161821	Stryker Universal Mesh	Stryker Corp.	GWO	Class II	2016-12-08
K161730	Wireless Digital Flat Panel Detector	Iray Technology (Shanghai), Ltd.	MQB	Class II	2016-12-08
K161632	FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)	Bios S.r.l.	GEX	Class II	2016-12-08
K161488	ESTETICA Dental Treatment Unit and Accessories	Kaltenbach & Voigt GmbH	EIA	Class I	2016-12-08
K161400	ImagingRing System	Medphoton GmbH	IYE	Class II	2016-12-08