Cleared Traditional

K915730 - MORTARA INSTRUMENT ODEL ELI 50I

K915730 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Mortara Instrument, Inc. devices

FDA 510(k) Submission Details - K915730

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 125d · This submission: 326d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 59
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K915730.
SPACE LABS MODEL 90560
K923788 · Spacelabs, Inc. · Dec 1993
MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION
K921669 · Marquette Electronics, Inc. · May 1993
SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM
K922221 · Del Mar Avionics · Apr 1993
MODEL ELI 200 ELECTROCARDIOGRAPH
K920626 · Mortara Instrument, Inc. · Sep 1992
MODEL ELI 100 ELECTROCARDIOGRAPH
K920627 · Mortara Instrument, Inc. · Sep 1992
MORTARA INSTRUMENT MODEL ECG PREVU
K920377 · Mortara Instrument, Inc. · Apr 1992