Cleared Traditional

K834569 - VENTILATORY FREQUENCY MONITOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K834569 · Cryo Corp. · Anesthesiology device
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Mar 1984
Decision
92d
Days
Class 1
Risk

K834569 is an FDA 510(k) clearance for the VENTILATORY FREQUENCY MONITOR. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Cryo Corp. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 Cryo Corp. devices

Submission Details

510(k) Number K834569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date March 30, 1984
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 139d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.