Cleared Traditional

SINGLE HANDED BREAST PUMP (K941112) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941112 · Macneil Baby Care , Ltd. · Obstetrics & Gynecology device
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Jan 1995
Decision
329d
Days
Class 2
Risk

K941112 is an FDA 510(k) clearance for the SINGLE HANDED BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Macneil Baby Care , Ltd. (Downers Grove, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Macneil Baby Care , Ltd. devices

Submission Details

510(k) Number K941112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date January 30, 1995
Days to Decision 329 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 160d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 238
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K941112.
Spectra Platinum Mini
K260956 · Uzinmedicare Co., Ltd. · Jun 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
K254300 · Anker Innovations Limited · May 2026
Wearable Breast Pump (Model S39)
K254244 · Shenzhen TPH Technology Co., Ltd. · May 2026
Electric Breast Pump (HL-3058 II Pro)
K254125 · Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. · May 2026
Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
K253914 · Shenzhen Root Innovation Technology Co., Ltd. · Apr 2026
Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
K260239 · Jiangxi AOV Maternity & Baby Products Co., Ltd. · Apr 2026