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MD400 A/B/C/D/E/F/G

by International Purification Systems, Inc.

510(k) K944385

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 NumberK944385 Date28 Apr 1995ClearedStatusActive

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  • Withdrawn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
FIP
Device Class
Class II
Regulation
21 CFR Part 876.5665
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 MD400 A/B/C/D/E/F/G is a water purification subsystem. It is designed to function as a filtration unit.

This device is regulated under FDA 510(k) clearance K944385. It is classified under regulation number 876.5665 within the gastroenterology and urology medical specialties.

Questions

AI-generated answers, 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.

  • What is the primary function of the MD400 A-G?

    The MD400 A/B/C/D/E/F/G is designed to function as a water purification subsystem, specifically serving as a filtration unit.

  • Which medical specialties is this device intended for?

    This device is classified under regulation number 876.5665, which falls within the gastroenterology and urology medical specialties.

  • What is the regulatory status of the MD400 series?

    The MD400 A/B/C/D/E/F/G is regulated under FDA 510(k) clearance K944385, which was granted on April 28, 1995.