Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more— 510(k) K261622

Name: FDA 510(k) clearance K261622
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Substantially Equivalent

Philips Consumer Lifestyle B.V.

FDA 510(k) clearance K261622 for Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more, Substantially Equivalent on 2026-09-03. Applicant: Philips Consumer Lifestyle B.V.. Device class: 2.

Clearance details

Device name as filed: Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)
Applicant: Philips Consumer Lifestyle B.V.
Product code: Code HGX
Device class: Class 2
Regulation: 21 CFR 884.5160
Advisory panel: Obstetrics/Gynecology
Date received: 2026-05-15
Decision date: 2026-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Drachten, NL

Download summary PDF View on FDA.gov ↗

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K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3)2026-07-24
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Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.