Cleared Traditional

K903011 - RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903011 · Non-Invasive Monitoring Systems, Inc. · Anesthesiology device
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Mar 1991
Decision
263d
Days
Class 2
Risk

K903011 is an FDA 510(k) clearance for the RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Non-Invasive Monitoring Systems, Inc. (Washington, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 263 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Non-Invasive Monitoring Systems, Inc. devices

Submission Details

510(k) Number K903011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1990
Decision Date March 29, 1991
Days to Decision 263 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 139d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 173
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K903011.
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