Skip to content

Hydrocheck Micro Filter

by White River Concepts

510(k) K970488

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 NumberK970488 Date4 Nov 1997ClearedStatusActive

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  • Withdrawn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
HGX
Device Class
Class II
Regulation
21 CFR Part 884.5160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Hydrocheck Micro Filter is a device classified as a Pump, Breast, Powered, according to the openfda device class. It is a medical device used in the field of Obstetrics/Gynecology.

The device is supplied with various registration numbers, including 3012298445, 3024790242, and 3020034975, and is regulated under the regulation number 884.5160. It has been authorized with an FDA 510K clearance, with a decision date of 1997-11-04, and is manufactured by White River Concepts.

Other devices from White River Concepts

Questions

AI-generated answers, 23 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 Hydrocheck Micro Filter used for?

    The Hydrocheck Micro Filter is used in the field of Obstetrics/Gynecology as a powered breast pump.

  • Is the Hydrocheck Micro Filter supplied sterile?

    The device data does not specify if the Hydrocheck Micro Filter is supplied sterile, it is recommended to check the packaging or manufacturer's instructions.

  • What is the regulatory classification of the Hydrocheck Micro Filter?

    The Hydrocheck Micro Filter is regulated under the regulation number 884.5160 and has been authorized with an FDA 510K clearance.