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Philips Avent Double Electric Breast Pump Advanced SCF394/61, SCF394/62

by Philips Consumer Lifestyle - Innovation Site Eindhoven

510(k) K203383

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203383↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Special NumberK203383 Date15 Dec 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
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, 18 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 (FDA classification: Class II) designed for electric, dual-channel milk expression. It is intended for use by lactating individuals to facilitate breastfeeding by mechanically extracting breast milk. The pump operates via motorised suction to mimic natural nursing, enabling efficient and comfortable milk removal.

The Philips Avent Double Electric Breast Pump Advanced is supplied as a reusable, non-sterile device intended for home or clinical use. It is authorised under FDA 510K clearance (Special 510(k), K203383) and MDR compliance, with regulatory registration numbers listed in the OpenFDA database. The device includes two adjustable suction settings (SCF394/61 and SCF394/62) and is intended for single-user use. Storage requires a clean, dry environment, and components should be washed and dried according to manufacturer instructions.

Other devices from Philips Consumer Lifestyle - Innovation Site Eindhoven

Questions

AI-generated answers, 18 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 are the key differences between the SCF394/61 and SCF394/62 models of the Philips Avent Double Electric Breast Pump Advanced?

    The Philips Avent Double Electric Breast Pump Advanced models SCF394/61 and SCF394/62 differ primarily in their adjustable suction settings, which cater to individual comfort and milk expression needs. Both models are designed for dual-channel electric pumping, but the specific suction profiles may vary slightly between them to accommodate different user preferences. The device is intended for single-user use, ensuring hygiene and personalization.

  • Is the Philips Avent Double Electric Breast Pump Advanced meant for clinical or home use, and how should it be maintained?

    The Philips Avent Double Electric Breast Pump Advanced is intended for both home and clinical use, as it is a reusable, non-sterile device. Maintenance involves washing and drying all components according to the manufacturer’s instructions to ensure proper hygiene. Storage should be in a clean, dry environment to prevent contamination or damage.

  • How is the Philips Avent Double Electric Breast Pump Advanced regulated, and what does that mean for buyers?

    The device holds FDA 510(k) clearance under Special 510(k) classification (K203383) and complies with the EU Medical Device Regulation (MDR). This means it has undergone evaluation by regulatory authorities to confirm it is substantially equivalent to a predicate device and meets safety and performance standards. Buyers can trust it has been assessed for compliance with applicable regulations.

  • Can this breast pump be shared between multiple users, and if not, why?

    No, the Philips Avent Double Electric Breast Pump Advanced is explicitly intended for single-user use only. This design choice ensures hygiene and prevents cross-contamination, which is critical for devices that come into direct contact with breast tissue and milk. Sharing could compromise safety and effectiveness.

  • What type of suction settings does the Philips Avent Double Electric Breast Pump Advanced offer, and how do they work?

    The pump features adjustable suction settings designed to mimic natural nursing and facilitate efficient milk expression. These settings allow users to customize the suction strength to their comfort level, promoting a more comfortable and effective pumping experience. The dual-channel design enables simultaneous pumping from both breasts, enhancing convenience.