Cleared Traditional

K973501 - EXPRESSE AND PREMIER POWERED BREAST PUMPS

K973501 is an FDA 510(k) clearance for EXPRESSE AND PREMIER POWERED BREAST PUMPS, manufactured by Ameda Medizintechnik AG. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K973501 · Ameda Medizintechnik AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
86d
Days
Class 2
Risk

K973501 is an FDA 510(k) clearance for the EXPRESSE AND PREMIER POWERED BREAST PUMPS. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Ameda Medizintechnik AG (Libertyville, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ameda Medizintechnik AG devices

FDA 510(k) Submission Details - K973501

510(k) Number K973501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1997
Decision Date December 11, 1997
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
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 K973501.
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HYDROCHECK MICRO FILTER
K970488 · White River Concepts · Nov 1997
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K971543 · Kaweco GmbH · Sep 1997
WHITE RIVER AUTOMATIC BREAST PUMP
K964679 · White River Concepts · Jun 1997