Cleared Traditional

K961972 - MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (FDA 510(k) Clearance)

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

K961972 · Aequitron Medical, Inc. · Anesthesiology device
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Apr 1997
Decision
333d
Days
Class 2
Risk

K961972 is an FDA 510(k) clearance for the MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 18, 1997 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Aequitron Medical, Inc. devices

Submission Details

510(k) Number K961972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 20, 1996
Decision Date April 18, 1997
Days to Decision 333 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 139d · This submission: 333d
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
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