Cleared Traditional

K895114 - FRANK MILK PUMP

K895114 is the FDA 510(k) clearance for FRANK MILK PUMP by Buttner-Frank GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K895114 · Buttner-Frank GmbH · Obstetrics & Gynecology device
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Mar 1990
Decision
202d
Days
Class 2
Risk

K895114 is an FDA 510(k) clearance for the FRANK MILK PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Buttner-Frank GmbH (Postfach 1266, DE). The FDA issued a Cleared decision on March 5, 1990 after a review of 202 days - an extended review 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: 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.

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Submission Details

510(k) Number K895114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date March 05, 1990
Days to Decision 202 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 160d · This submission: 202d
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.