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Whittlestone Breastpump

by Whittlestone, Inc.

510(k) K002696

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 NumberK002696 Date21 Mar 2001ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Whittlestone Breastpump is a powered breast pump designed for milk expression. It is a Class II medical device intended for use in obstetrics and gynecology settings.

The device is supplied as a non-sterile, reusable product. It is not MRI compatible and should be stored according to manufacturer instructions. The Whittlestone Breastpump has FDA 510(k) clearance with product code HGX and was cleared on March 21, 2001.

Other devices from Whittlestone, Inc.

Questions

AI-generated answers, 1 Oct 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 Whittlestone Breastpump used for?

    The Whittlestone Breastpump is a powered medical device designed for milk expression in obstetrics and gynecology settings. It is intended for use in clinical environments where breast milk expression is required.

  • Is the Whittlestone Breastpump sterile or single-use?

    The Whittlestone Breastpump is supplied as a non-sterile, reusable product. It is designed for multiple uses and should be cleaned and stored according to the manufacturer's instructions between uses.

  • What regulatory approvals does the Whittlestone Breastpump have?

    The Whittlestone Breastpump has FDA 510(k) clearance with product code HGX, cleared on March 21, 2001. It is classified as a Class II medical device and is substantially equivalent to other devices in its category.

  • Is the Whittlestone Breastpump MRI compatible?

    No, the Whittlestone Breastpump is not MRI compatible. Users should avoid using this device in MRI environments or near strong magnetic fields as specified in the manufacturer instructions.