Cleared Traditional

K952713 - MINI WRIGHT LR AFS

K952713 is the FDA 510(k) clearance for MINI WRIGHT LR AFS by Clement Clarke, Inc.. It is a Class 2 Anesthesiology device (product code BZH) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K952713 · Clement Clarke, Inc. · Anesthesiology device
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Mar 1996
Decision
289d
Days
Class 2
Risk

K952713 is an FDA 510(k) clearance for the MINI WRIGHT LR AFS. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Clement Clarke, Inc. (England, GB). The FDA issued a Cleared decision on March 29, 1996 after a review of 289 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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, Inc. devices

Submission Details

510(k) Number K952713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1995
Decision Date March 29, 1996
Days to Decision 289 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 140d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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.