Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) +1 more— 510(k) K261622
Substantially EquivalentPhilips 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.
Summary
Philips Consumer Lifestyle's clearance covers two Philips Avent Natural Care hands-free wearable electric breast pumps, each in two models: the standard pump (SCF593/52, SCF593/62) and a Warming version (SCF594/52, SCF594/62). Product code HGX is powered breast pumps.
Class II, 21 CFR 884.5160. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Philips filed from Drachten, the Netherlands. The decision came 111 calendar days after FDA received it (May 15 to September 3, 2026).
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
- Product code HGX
- Device class
- Class 2
- Regulation
- 21 CFR 884.5160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Drachten, NL
Recent devices under product code HGX
view allMore clearances from Philips Consumer Lifestyle B.V.
view allAdverse events under product code HGX
product code HGX- Injury
- 758
- Other
- 2
- Total
- 760
Source: openFDA MAUDE database, through . 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.