Cleared Traditional

K915730 - MORTARA INSTRUMENT ODEL ELI 50I (FDA 510(k) Clearance)

K915730 · Mortara Instrument, Inc. · Cardiovascular device
Nov 1992
Decision
326d
Days
-
Risk

K915730 is an FDA 510(k) clearance for the MORTARA INSTRUMENT ODEL ELI 50I.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 10, 1992 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K915730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date November 10, 1992
Days to Decision 326 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 140d · This submission: 326d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -