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FDA 510(k)

X-FLO Fluid Management System

K-Number: K210628 · 2021-11-04

ApplicantThermedx, LLC
Decision Date2021-11-04
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

X-FLO Fluid Management System is a medical device manufactured by Thermedx, LLC. It received FDA 510(k) clearance on 2021-11-04 under approval number K210628. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-FLO Fluid Management System?

X-FLO Fluid Management System is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Thermedx, LLC. The 510(k) number is K210628.

When was X-FLO Fluid Management System approved by the FDA?

X-FLO Fluid Management System received FDA 510(k) clearance on 2021-11-04, under approval number K210628.

What company makes X-FLO Fluid Management System?

X-FLO Fluid Management System is manufactured by Thermedx, LLC.

What is the FDA product code for X-FLO Fluid Management System?

The FDA product code for X-FLO Fluid Management System is HIG.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT07612644 Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS) RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING

Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (2025)

Other Devices by Thermedx, LLC

K172048FluidSmart

Related Devices (Code: HIG)

K172048FluidSmartThermedx, LLC K180735Endomat SelectKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc. K173489GYN-Pump PH304W.O.M. World of Medicine GmbH K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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