Cleared Traditional

K974581 - MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT

K974581 is an FDA 510(k) clearance for MILLENNIA 3500 SERIES MONITOR WITH ANTH..., manufactured by Invivo Research, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K974581 · Invivo Research, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
324d
Days
Class 2
Risk

K974581 is an FDA 510(k) clearance for the MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Invivo Research, Inc. (Orlando, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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. Elevated predicate reliance profile. 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 Invivo Research, Inc. devices

FDA 510(k) Submission Details - K974581

510(k) Number K974581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date October 28, 1998
Days to Decision 324 days
Submission Type Traditional
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
199d slower than avg
Panel avg: 125d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 203
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K974581.
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ATLAS MONITOR
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PASSPORT 5L-CE MODEL 0998-00-0131XXX
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NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998
HEART PROTECTOR (VER 1996)
K965158 · N.P.N.T., Inc. · Dec 1997