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Unimom Allegro

by Blue Egg CO

510(k) K100929

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 NumberK100929 Date16 Jun 2010ClearedStatusActive

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  • Withdrawn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 Unimom Allegro is a powered breast pump classified as a Class II medical device in the Obstetrics/Gynecology specialty. It is designed for milk expression and is intended for use in healthcare settings or at home.

The device is supplied by Blue Egg CO and received FDA 510(k) clearance on June 16, 2010, with the product code HGX. It is regulated under 884.5160 and was reviewed by the Obstetrics/Gynecology advisory committee. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

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 UNIMOM ALLEGRO used for?

    The UNIMOM ALLEGRO is a powered breast pump designed for milk expression. It is intended for use in healthcare settings or at home by individuals who need to express breast milk.

  • Is the UNIMOM ALLEGRO single-use or reusable?

    The device is not specified as single-use or reusable in the available information. Users should consult the manufacturer's instructions for specific guidance on reuse or disposal.

  • What regulatory approvals does the UNIMOM ALLEGRO have?

    The UNIMOM ALLEGRO received FDA 510(k) clearance on June 16, 2010, with product code HGX. It is classified as a Class II medical device in the Obstetrics/Gynecology specialty and regulated under 884.5160.

  • What sizes and models of the UNIMOM ALLEGRO are available?

    The available information does not specify different sizes or models of the UNIMOM ALLEGRO. The device is identified by its model name UNIMOM ALLEGRO and product code HGX.