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Soaker Catheter

by I-Flow Corp. 510(k)

Active United States

510(k) K994374

Overview

The Soaker Catheter is a medical device designed for the continuous or intermittent delivery of fluids, typically used in pain management systems. It functions as a conduit for irrigation or infusion, facilitating the administration of local anesthetics or other therapeutic agents directly to surgical sites or nerve blocks.

This device is intended for single-use and is supplied sterile, requiring no additional preparation before use. It is classified as a Class II medical device under FDA regulations and has been cleared through a 510(k) premarket notification process. The Soaker Catheter is compatible for use in general hospital settings and is distributed by I-Flow Corp.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994374 Date3 Mar 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary purpose of the Soaker Catheter in clinical settings?

    The Soaker Catheter is designed for continuous or intermittent delivery of fluids, such as local anesthetics or therapeutic agents, directly to surgical sites or nerve blocks. This helps manage pain by facilitating irrigation or infusion during procedures, ensuring targeted treatment at the site of interest.

  • Is the Soaker Catheter intended for single-use or reusable applications?

    The Soaker Catheter is explicitly designed for single-use only. It is supplied sterile and requires no additional preparation before use, ensuring patient safety and compliance with medical device standards.

  • How is the Soaker Catheter regulated in the U.S., and what does that mean for hospitals?

    The Soaker Catheter has been cleared through the FDA’s 510(k) premarket notification process and is classified as a Class II medical device. This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device, allowing hospitals to use it with confidence in general surgical or pain management settings.

  • Where can the Soaker Catheter be used, and what types of facilities typically utilize it?

    The Soaker Catheter is intended for use in general hospital settings, including operating rooms, pain management clinics, or procedural suites where irrigation or infusion of therapeutic fluids is required. Its design aligns with standard hospital workflows for pain management systems.

  • Does the Soaker Catheter come pre-sterilized, or does it require sterilization before use?

    Yes, the Soaker Catheter is supplied sterile and does not require additional sterilization before use. This ensures immediate readiness for clinical procedures without extra preparation steps.