FDA cleared the 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) from Philips Consumer Lifestyle B.V. on Sep 3, 2026 under K261622, a traditional 510(k). The device falls under product code HGX, Pump, Breast, Powered, regulated at 21 CFR 884.5160 as a Class 2 device. The review panel was Obstetrics/Gynecology.
FDA logged the submission as received on May 15, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Philips Consumer Lifestyle B.V. has one other decision in the tracker over the last 12 months: K253754 (Philips Lumea IPL).
Questions & Answers
What did FDA clear under K261622?
K261622 is the FDA 510(k) for 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), submitted by Philips Consumer Lifestyle B.V.. FDA's decision date was Sep 3, 2026, under product code HGX (Pump, Breast, Powered).
Who makes the 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)?
Philips Consumer Lifestyle B.V., based in Drachten, is the applicant of record for K261622.
How long did the K261622 review take?
FDA received the submission on May 15, 2026 and issued its decision on Sep 3, 2026, 111 days later.