Cleared Traditional

K921261 - ELECTRIC POWERED BREAST PUMP

K921261 is an FDA 510(k) clearance for ELECTRIC POWERED BREAST PUMP, manufactured by Schuco, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 603-day FDA review.

K921261 · Schuco, Inc. · Obstetrics & Gynecology device
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Nov 1993
Decision
603d
Days
Class 2
Risk

K921261 is an FDA 510(k) clearance for the ELECTRIC POWERED BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Schuco, Inc. (Toledo, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 603 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Schuco, Inc. devices

FDA 510(k) Submission Details - K921261

510(k) Number K921261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date November 09, 1993
Days to Decision 603 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
443d slower than avg
Panel avg: 160d · This submission: 603d
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 Peers - HGX Pump, Breast, Powered

All 211
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K921261.
WHITE RIVER BATTERY-POWERED BREAST PUMP
K952712 · Natural Technologies, Inc. · Apr 1996
MEDELAS BREAST PUMP
K950750 · Medela, Inc. · Oct 1995
EGNELL ELITE
K950531 · Hollister, Inc. · Sep 1995
MEDELA BATTERY OPERATED BREAST PUMP
K901344 · Medela, Inc. · Aug 1990
MEDELA BREAST-PUMP LACTINA
K875300 · Medela, Inc. · Apr 1988
MEDELA ELECTRIC BREAST PUMP
K801862 · Medela, Inc. · Oct 1980