Cleared Traditional

K042058 - ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN

K042058 is an FDA 510(k) clearance for ONEFLOW FVC, manufactured by Clement Clarke Intl., Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K042058 · Clement Clarke Intl., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042058

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 140d · This submission: 236d
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
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K042058.
SPIROTEL
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SPIRO'AIR
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LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K033518 · Custom Plastic Products · Mar 2004
FLOSENSE II, MODEL 29-8040
K033939 · Sdi Diagnostics, Inc. · Jan 2004
SPIROTEL, MODEL 29-1020
K031643 · Sdi Diagnostics, Inc. · Dec 2003