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Whittlestone Expresser

by Whittlestone, Inc.

510(k) K051112

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 NumberK051112 Date7 Sep 2005ClearedStatusActive

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  • Withdrawn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, 19 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 Whittlestone Expresser is a powered breast pump classified as a Pump, Breast, Powered. It is designed to mechanically assist lactating individuals in expressing breast milk through controlled suction, providing an alternative to manual expression methods.

This device is intended for use in obstetrics and gynecology settings, supplied as a reusable medical instrument. It operates via electrical power and requires proper cleaning and maintenance as outlined in accompanying instructions. The device holds an FDA 510(k) clearance under the classification of Class II, with registration numbers including 3012298445 and others, and is governed by regulation 884.5160.

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