Cleared Traditional

LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 (K033518) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033518 · Custom Plastic Products · Anesthesiology device
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Mar 2004
Decision
124d
Days
Class 2
Risk

K033518 is an FDA 510(k) clearance for the LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Custom Plastic Products (Laguna Niguel, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 124 days - within the typical 510(k) review window.

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. 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.

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Submission Details

510(k) Number K033518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date March 10, 2004
Days to Decision 124 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 140d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
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