Cleared Traditional

K840488 - LIFECYCLE AEROBIC MONITOR 123 (FDA 510(k) Clearance)

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

K840488 · Heart Rate, Inc. · Anesthesiology device
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May 1984
Decision
114d
Days
Class 2
Risk

K840488 is an FDA 510(k) clearance for the LIFECYCLE AEROBIC MONITOR 123. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Heart Rate, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 114 days - within the typical 510(k) review window.

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 Heart Rate, Inc. devices

Submission Details

510(k) Number K840488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date May 30, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 139d · This submission: 114d
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 K840488.
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