Cleared Abbreviated

K032338 - TRIO MONITOR MODEL 0998-00-0600

K032338 is an FDA 510(k) clearance for TRIO MONITOR MODEL 0998-00-0600, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Abbreviated 510(k) pathway after a 197-day FDA review.

K032338 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
197d
Days
Class 2
Risk

K032338 is an FDA 510(k) clearance for the TRIO MONITOR MODEL 0998-00-0600. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on February 11, 2004 after a review of 197 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K032338

510(k) Number K032338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2003
Decision Date February 11, 2004
Days to Decision 197 days
Submission Type Abbreviated
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
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K032338.
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MODIFICATION TO UNITY NETWORK ID
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M2376A PHILIPS DEVICE LINK SYSTEM
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K032867 · Larsen & Toubro Limited · Nov 2003
K032338 · TRIO MONITOR MODEL 0998-00-0600
Download PDF FDA Summary Datascope Corp.