Cleared Traditional

K832678 - PHONATORY FUNCTION ANALYZER PS-77 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K832678 · Kells Medical, Inc. · Anesthesiology device
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Mar 1984
Decision
211d
Days
Class 1
Risk

K832678 is an FDA 510(k) clearance for the PHONATORY FUNCTION ANALYZER PS-77. Classified as Transducer, Gas Flow (product code BXP), Class I - General Controls.

Submitted by Kells Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1984 after a review of 211 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2885 - 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 Kells Medical, Inc. devices

Submission Details

510(k) Number K832678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date March 07, 1984
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 139d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXP Transducer, Gas Flow
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2885
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.