Cleared Traditional

K261622 - Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62)

Also marketed or referenced as:
Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)

K261622 is an FDA 510(k) clearance for Philips Avent Natural Care Hands-free W..., manufactured by Philips Consumer Lifestyle B.V.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K261622 · Philips Consumer Lifestyle B.V. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
111d
Days
Class 2
Risk

K261622 is an FDA 510(k) clearance for the Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: S.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Philips Consumer Lifestyle B.V. (Drachten, NL). The FDA issued a Cleared decision on September 3, 2026 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Consumer Lifestyle B.V. devices

FDA 510(k) Submission Details - K261622

510(k) Number K261622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date September 03, 2026
Days to Decision 111 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 161d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Philips Personal Health, a subsidiary of Philips North America, LLC
Shaylee Masilunas

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 227
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K261622.
Wearable Breast Pump (Model S36)
K254203 · Shenzhen TPH Technology Co., Ltd. · Sep 2026
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)
K262774 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Sep 2026
Cimilre Dual Max
K260643 · Cimilre Co., Ltd. · Aug 2026
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
K261298 · Guangdong Youmeng Electrical Technology Co., Ltd. · Aug 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · Shenzhen TPH Technology Co., Ltd. · Jul 2026
Wearable Breast Pump (Model S32A)
K261199 · Shenzhen TPH Technology Co., Ltd. · Jul 2026