Cleared Traditional

K854062 - PALL PULMONARY FUNCTION FILTER

K854062 is an FDA 510(k) clearance for PALL PULMONARY FUNCTION FILTER, manufactured by Pall Biomedical Products Co.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K854062 · Pall Biomedical Products Co. · Anesthesiology device
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Nov 1985
Decision
34d
Days
Class 2
Risk

K854062 is an FDA 510(k) clearance for the PALL PULMONARY FUNCTION FILTER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Pall Biomedical Products Co. (Glen Cove, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pall Biomedical Products Co. devices

FDA 510(k) Submission Details - K854062

510(k) Number K854062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date November 07, 1985
Days to Decision 34 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
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BZG Spirometer, Diagnostic

All 69
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K854062.
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986
MODEL 2120 SPIROSCREEN
K854403 · Gould, Inc. · Jan 1986
VITALOGRAPH COMPACT
K854526 · Vitalograph , Ltd. · Dec 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
PULMONARY TEST SYSTEM FUDAC-30
K852307 · Futuremed Div. of Future Impex Corp. · Jul 1985
SPIRO SCAN
K851135 · Brentwood Instruments, Inc. · Jul 1985