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Natural Comfort Double Electric/Battery Breast Pump, Model 1181/1068

by The First Years, Inc.

510(k) K033131

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 · Special NumberK033131 Date30 Oct 2003ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

This device is a powered breast pump designed for expressing breast milk. It operates using either electric power or battery power and is intended for use by lactating individuals to extract milk from the breasts.

The pump is supplied as a reusable device and is not sterile. It is classified as a Class II medical device under FDA regulation 884.5160 and has received FDA 510(k) clearance (K033131) as substantially equivalent to a legally marketed predicate device. No information regarding MRI safety, specific sizes, or storage conditions is provided in the data.

Other devices from The First Years, Inc.

Questions

AI-generated answers, 23 Sep 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 NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP used for?

    This device is designed for expressing breast milk and is intended for use by lactating individuals to extract milk from the breasts, operating via either electric or battery power.

  • Is the NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP sterile or single-use?

    The pump is supplied as a reusable device and is not sterile, meaning it is intended for multiple uses after proper cleaning by the user, not for single-use or sterile applications.

  • What regulatory pathway was used for the NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP?

    The device received FDA 510(k) clearance under K033131, demonstrating it is substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under regulation 884.5160.