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Pressurized Infusion Pump

by Mui Scientific

510(k) K122294

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122294 Date1 Nov 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FFX
Device Class
Class II
Regulation
21 CFR Part 876.1725
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pressurized Infusion Pump is a gastrointestinal motility system designed to provide continuous perfusion for clinical diagnostics. It utilizes a miniature air compressor to pressurize a cylinder with dry air, maintaining consistent pressure levels for up to two hours of operation.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance. It is categorized under the gastroenterology and urology medical specialties and is identified by product code FFX.

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