Cleared Traditional

K834292 - PALL HEAT MOISTURE EXCHANGING FILTER

K834292 is an FDA 510(k) clearance for PALL HEAT MOISTURE EXCHANGING FILTER, manufactured by Pall Biomedical Products Co.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K834292 · Pall Biomedical Products Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K834292

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

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.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 33
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K834292.
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · American Pharmaseal Div. Ahsc · Dec 1985
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
K844040 · Siemens Elema AB · Oct 1984
INLINE FOAM NOSE
K840398 · Mallinckrodt Critical Care · Mar 1984
FOAM NOSE
K840399 · Mallinckrodt Critical Care · Mar 1984
ENGSTOM EDITH
K821365 · Lkb Instruments, Inc. · Jun 1982