Cleared Traditional

K834292 - PALL HEAT MOISTURE EXCHANGING FILTER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K834292 · Pall Biomedical Products Co. · Anesthesiology device
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Apr 1984
Decision
118d
Days
Class 1
Risk

K834292 is an FDA 510(k) clearance for the PALL HEAT MOISTURE EXCHANGING FILTER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Pall Biomedical Products Co. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Pall Biomedical Products Co. devices

Submission Details

510(k) Number K834292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date April 04, 1984
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 139d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
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.