Cleared Traditional

K952713 - MINI WRIGHT LR AFS

K952713 is an FDA 510(k) clearance for MINI WRIGHT LR AFS, manufactured by Clement Clarke, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K952713

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
Combination Product No
PCCP Authorized No
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.

BZH Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 47
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K952713.
PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
K962924 · Healthscan Products, Inc. · Oct 1996
PERSONAL BEST II
K962929 · Healthscan Products, Inc. · Oct 1996
BREATH-TAKER BREATH-ALERT
K953411 · Roxon - Universal Medical , Ltd. · Jun 1996
AUTOZONE
K952909 · Health Scan, Inc. · Mar 1996
TRUPEAK PEAK FLOW METER
K955234 · Monaghan Medical Corp. · Mar 1996
TRUZONE PEAK FLOW METER
K955262 · Monaghan Medical Corp. · Mar 1996