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Lactation Techniques Model B

by Lactation Techniques, Inc.

510(k) K981549

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 NumberK981549 Date24 May 1999ClearedStatusActive

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  • Withdrawn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, 26 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 Lactation Techniques Model B is a powered breast pump designed to aid nursing mothers with the extraction of breast milk. It is an auto-cycling device intended for home use. The device functions as a breast pump, and its primary purpose is to assist in the expression of breast milk in situations where the nursing child is temporarily absent.

The Lactation Techniques Model B is supplied as a single device and is intended for use by nursing mothers at home. It is a powered device, and its use is regulated under the product code HGX and regulation number 884.5160. The device has been cleared under FDA 510(k) number K981549, and it is not specified as sterile or single-use. Storage and MRI safety information are not provided.