Cleared Traditional

K053156 - MINI-WRIGHT DIGITAL

K053156 is an FDA 510(k) clearance for MINI-WRIGHT DIGITAL, manufactured by Clement Clarke Intl., Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K053156 · Clement Clarke Intl., Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
78d
Days
Class 2
Risk

K053156 is an FDA 510(k) clearance for the MINI-WRIGHT DIGITAL, MODEL 3120001. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Clement Clarke Intl., Ltd. (Harlow, GB). The FDA issued a Cleared decision on January 31, 2006 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clement Clarke Intl., Ltd. devices

FDA 510(k) Submission Details - K053156

510(k) Number K053156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date January 31, 2006
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 27
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K053156.
Besmed Peak Flow Meter
K172804 · Besmed Health Business Corp · Jan 2018
STRIVE DUAL ZONE PEAK FLOW METER
K123945 · Monaghan Medical Corp. · Apr 2013
PEAK EXPIRATORY FLOW METER, KN-9710
K092335 · K-Jump Health Co., Ltd. · Apr 2010
PMP4 SPIROPRO
K050853 · Card Guard Scientific Survival , Ltd. · May 2005
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K040723 · Microlife Intellectual Property GmbH · Jun 2004
MODIFICATION TO TRUPEAK PEAK FLOW METER
K031514 · Monaghan Medical Corp. · May 2003