Cleared Traditional

K042758 - POLYTECH PULMONARY FUNCTION FILTER

K042758 is an FDA 510(k) clearance for POLYTECH PULMONARY FUNCTION FILTER, manufactured by Polytechnic Resources, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K042758 · Polytechnic Resources, Inc. · Anesthesiology device
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Aug 2005
Decision
329d
Days
Class 2
Risk

K042758 is an FDA 510(k) clearance for the POLYTECH PULMONARY FUNCTION FILTER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Polytechnic Resources, Inc. (Baltimore, US). The FDA issued a Cleared decision on August 29, 2005 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042758

510(k) Number K042758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date August 29, 2005
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
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 158
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