Cleared Traditional

K900720 - MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)

K900720 is an FDA 510(k) clearance for MORTARA INSTRUMENT MODEL X-SCRIBE (TREA..., manufactured by Mortara Instrument, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K900720

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.

DSI Device Classification - Class 2, Special Controls

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 285
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K900720.
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FUKUDA DENSHI MODEL LX-3100
K903514 · Fukuda Denshi USA, Inc. · Jan 1991
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · Fukuda Denshi USA, Inc. · Sep 1990
TRAM PATIENT MONITOR
K900540 · Marquette Electronics, Inc. · Jul 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246 · Ppg Industries, Inc. · Jul 1990