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Klein Touch Pump and Disposable Tubing Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123822

by Hk Surgical Inc.

Identifiers

510(k) Number
K123822 FDA 510(k)
FDA Product Code
FRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a pump, infusion, as defined by its device type and nomenclature. It consists of the Klein Touch Pump and a disposable tubing set designed for use in tumescent procedures.

It is supplied as a system comprising an electrically or battery-operated, manually controlled peristaltic pump and single-use tubing with a luer lock fitting. The device is intended for use in general hospital settings and has received FDA 510(k) clearance under regulation number 880.5725.

Frequently asked questions

What is the Klein Touch Pump and disposable tubing set used for?

The device is intended for use in tumescent procedures, where it delivers fluids via a peristaltic pumping mechanism using a disposable tubing set with a luer lock fitting, designed for general hospital settings.

How is the Klein Touch Pump and disposable tubing set supplied and is it reusable?

It is supplied as a system comprising an electrically or battery-operated, manually controlled peristaltic pump and a single-use disposable tubing set with a luer lock fitting; the tubing is intended for single use only to prevent cross-contamination.

What regulatory clearance does the Klein Touch Pump and disposable tubing set have?

The device has received FDA 510(k) clearance under regulation number 880.5725, with a traditional clearance pathway and a substantially equivalent decision based on its pump, infusion device type.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HK Surgical: Your Complete Tumescent Solution, Surgical Tubing for Tumescent Procedures | HK Surgical, K123822 - Klein Touch Pump and Disposable Tubing Set, Klein Touch Pump and Disposable Tubing Set

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hk Surgical Inc.
FDA Applicant
Hk Surgical, Inc.

Sources (1)

  • FDA 510(k) K123822 24 fields · synced Sep 25, 2026