Cleared Special

K203383 - Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62

K203383 is an FDA 510(k) clearance for Philips Avent Double electric breast pu..., manufactured by Philips Consumer Lifestyle - Innovation Site Eindhoven. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 28-day FDA review.

K203383 · Philips Consumer Lifestyle - Innovation Site Eindhoven · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
28d
Days
Class 2
Risk

K203383 is an FDA 510(k) clearance for the Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent D.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Philips Consumer Lifestyle - Innovation Site Eindhoven (Eindhoven, NL). The FDA issued a Cleared decision on December 15, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K203383

510(k) Number K203383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2020
Decision Date December 15, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 161d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HGX Device Classification - Class 2, Special Controls

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 254
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K203383 · Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
Download PDF FDA Summary Philips Consumer Life…