Cleared Special

K051897 - TRIO MONITOR

K051897 is the FDA 510(k) clearance for TRIO MONITOR by Datascope Corp.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 30-day FDA review.

K051897 · Datascope Corp. · Cardiovascular device
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Aug 2005
Decision
30d
Days
Class 2
Risk

K051897 is an FDA 510(k) clearance for the TRIO MONITOR. 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 August 12, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datascope Corp. devices

Submission Details

510(k) Number K051897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2005
Decision Date August 12, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 123
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K051897.
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
K053193 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
PM-9000 EXPRESS PATIENT MONITOR
K053234 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
K053027 · Welch Allyn, Inc. · Nov 2005
UNITY NETWORK ID
K051518 · Ge Medical Systems Information Technologies · Jul 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
TRIO MONITOR
K041907 · Datascope Corp. · Jul 2004