Cleared Traditional

TELEMETRY POWER PACK MODEL 2 (K891927) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K891927 · Lucas & Rhea Mfg. · Gastroenterology & Urology device
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Apr 1990
Decision
394d
Days
Class 1
Risk

K891927 is an FDA 510(k) clearance for the TELEMETRY POWER PACK MODEL 2. Classified as Box, Battery, Pocket (product code FCP), Class I - General Controls.

Submitted by Lucas & Rhea Mfg. (Lavinia, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lucas & Rhea Mfg. devices

Submission Details

510(k) Number K891927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date April 26, 1990
Days to Decision 394 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
264d slower than avg
Panel avg: 130d · This submission: 394d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCP Box, Battery, Pocket
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.