Cleared Traditional

K832678 - PHONATORY FUNCTION ANALYZER PS-77

K832678 is an FDA 510(k) clearance for PHONATORY FUNCTION ANALYZER PS-77, manufactured by Kells Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BXP cleared through the Traditional 510(k) pathway after a 211-day FDA review.

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

FDA 510(k) Submission Details - K832678

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
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

BXP Device Classification - Class 1, General Controls

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.