Data / Medical devices / United States / NextPhase Medical Devices, LLC

NextPhase Medical Devices, LLC: FDA-registered device maker in Mansfield, MA, United States, 1 510(k) clearance

Name: NextPhase Medical Devices, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

NextPhase Medical Devices, LLC is registered with the FDA (registration 3003174284) in Mansfield, MA, United States. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003174284
Address: 110 Forbes BLVD., Mansfield, MA, United States, 02048
Owner or operator: NextPhase Medical Devices, LLC (9050650)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: January 31, 2013
Registered through: 2026
Brand names listed: CO2 Insufflator, Codman OR Prep Kits, HTA Hysteroscope Adapter, Prometra, Sensinel Cardiopulmonary Management System

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Contract manufacturer	accessdata.fda.gov
Artificial Heart	LOZ	3	Contract manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Contract manufacturer	accessdata.fda.gov
Insufflator, Automatic Carbon-Dioxide For Endoscope	FCX	2	Manufacturer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Contract manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Contract manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Contract manufacturer	accessdata.fda.gov
Pump, Infusion, Implanted, Programmable	LKK	3	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Stethoscope, Electronic	DQD	2	Contract manufacturer	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 29, 2016	K162332	Nexcore GI Insufflator	FCX	Substantially Equivalent	Nexcore Technology, LLC	accessdata.fda.gov

Compare with other makers

Updated September 29, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.