Cleared Traditional

K900720 - MORTARA INSTRUMENT MODEL X-SCRIBE (TREA...

K900720 is the FDA 510(k) clearance for MORTARA INSTRUMENT MODEL X-SCRIBE (TREA... by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K900720 · Mortara Instrument, Inc. · Cardiovascular device
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Nov 1990
Decision
264d
Days
Class 2
Risk

K900720 is an FDA 510(k) clearance for the MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED). Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K900720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1990
Decision Date November 05, 1990
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 191
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K900720.
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