Cleared Traditional

K841104 - ENTERNAL FEEDING PUMP BATTERY OPER. (FDA 510(k) Clearance)

K841104 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Apr 1985
Decision
412d
Days
-
Risk

K841104 is an FDA 510(k) clearance for the ENTERNAL FEEDING PUMP BATTERY OPER..

Submitted by Fresenius USA, Inc. (Walker, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Gastroenterology & Urology submissions.

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Submission Details

510(k) Number K841104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1984
Decision Date April 30, 1985
Days to Decision 412 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
282d slower than avg
Panel avg: 130d · This submission: 412d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -