Cleared Traditional

K042058 - ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN (FDA 510(k) Clearance)

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

K042058 · Clement Clarke Intl., Ltd. · Anesthesiology device
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Mar 2005
Decision
236d
Days
Class 2
Risk

K042058 is an FDA 510(k) clearance for the ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Clement Clarke Intl., Ltd. (Harlow, GB). The FDA issued a Cleared decision on March 23, 2005 after a review of 236 days - an extended review 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: 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 Clement Clarke Intl., Ltd. devices

Submission Details

510(k) Number K042058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date March 23, 2005
Days to Decision 236 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
97d slower than avg
Panel avg: 139d · This submission: 236d
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.

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