Cleared Abbreviated

K041907 - TRIO MONITOR

K041907 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 Abbreviated 510(k) pathway after a 8-day FDA review.

K041907 · Datascope Corp. · Cardiovascular device
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Jul 2004
Decision
8d
Days
Class 2
Risk

K041907 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 July 23, 2004 after a review of 8 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. 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.

View all Datascope Corp. devices

Submission Details

510(k) Number K041907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2004
Decision Date July 23, 2004
Days to Decision 8 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
BAHRAM BARZIDEH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K041907.
TRIO MONITOR
K051897 · Datascope Corp. · Aug 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
MODIFICATION TO UNITY NETWORK ID
K040559 · Ge Medical Systems Information Technologies · Jun 2004
MODIFICATION TO M2376A DEVICELINK SYSTEM
K041401 · Philips Medical Systems · Jun 2004
TRIO MONITOR MODEL 0998-00-0600
K032338 · Datascope Corp. · Feb 2004

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.