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Egnell-Lact B Battery-Operated Breast Pump

by Egnell, Inc.

510(k) K844307

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 NumberK844307 Date4 Feb 1985ClearedStatusActive

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  • Withdrawn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 Egnell-Lact B Battery-Operated Breast Pump is a powered breast pump designed for manual milk expression. Classified as a breast pump under the FDA’s Pump, Breast, Powered category, it is intended to assist mothers in extracting breast milk through battery-powered operation, replicating the natural sucking rhythm for comfort and efficiency.

This device is supplied as a reusable medical instrument and is intended for use in obstetrics and gynecology settings. It operates via battery power and requires no MRI compatibility considerations. The device holds an FDA 510(k) clearance under K844307, with a classification of Class II. No sterility or single-use specifications are noted in the regulatory data.

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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 Egnell-Lact B Battery-Operated Breast Pump used for?

    The Egnell-Lact B is a powered breast pump designed for manual milk expression, intended to assist mothers in extracting breast milk through battery-powered operation that replicates the natural sucking rhythm for comfort and efficiency.

  • Is the Egnell-Lact B a single-use device or can it be reused?

    The Egnell-Lact B is supplied as a reusable medical instrument, meaning it can be used multiple times after proper cleaning and maintenance according to manufacturer instructions.

  • What regulatory status does the Egnell-Lact B have?

    The Egnell-Lact B holds FDA 510(k) clearance under K844307, classified as Class II under the FDA's Pump, Breast, Powered category, and is substantially equivalent to predicate devices.

  • In what settings is the Egnell-Lact B intended to be used?

    This device is intended for use in obstetrics and gynecology settings, where it assists with manual milk expression for nursing mothers.