Cleared Traditional

K971543 - LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP

K971543 is an FDA 510(k) clearance for LUXMATIC 12-15 ISC PORTABLE ELECTRIC BR..., manufactured by Kaweco GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K971543 · Kaweco GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
143d
Days
Class 2
Risk

K971543 is an FDA 510(k) clearance for the LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Kaweco GmbH (Great Neck,, US). The FDA issued a Cleared decision on September 18, 1997 after a review of 143 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 Kaweco GmbH devices

FDA 510(k) Submission Details - K971543

510(k) Number K971543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date September 18, 1997
Days to Decision 143 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
17d faster than avg
Panel avg: 160d · This submission: 143d
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 162
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K971543.
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · Medela, Inc. · Mar 2002
EXPRESSE AND PREMIER POWERED BREAST PUMPS
K973501 · Ameda Medizintechnik AG · Dec 1997
HYDROCHECK MICRO FILTER
K970488 · White River Concepts · Nov 1997
WHITE RIVER AUTOMATIC BREAST PUMP
K964679 · White River Concepts · Jun 1997
DOUBLE UP BREAST PUMP
K964396 · The Natural Choice Co., Inc. · Jun 1997
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
K964403 · The First Years, Inc. · Jan 1997