Cleared Traditional

K941226 - AIRWATCH MONITOR

K941226 is an FDA 510(k) clearance for AIRWATCH MONITOR, manufactured by Enact Health Management Systems. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K941226 · Enact Health Management Systems · Anesthesiology device
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Nov 1994
Decision
247d
Days
Class 2
Risk

K941226 is an FDA 510(k) clearance for the AIRWATCH MONITOR. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Enact Health Management Systems (North Attleboro, US). The FDA issued a Cleared decision on November 16, 1994 after a review of 247 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.

FDA 510(k) Submission Details - K941226

510(k) Number K941226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date November 16, 1994
Days to Decision 247 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
107d slower than avg
Panel avg: 140d · This submission: 247d
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 75
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K941226.
RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
K953458 · Raiinbow Step UP Systems, Inc. · Nov 1995
CARD GUARD
K934795 · Card Guard Scientific Survival , Ltd. · Apr 1995
ASPIRE
K936110 · Dura Pharmaceuticals, Inc. · Mar 1995
PEAKLOG AND DISPLAY SOFTWARE
K940835 · Medtrac Technologies Corp. · Nov 1994
PEAKLOG AND DISPLAY SOFTWARE
K940836 · Tamarac Systems Corp. · Nov 1994
FLOW=MED
K924322 · International Electronic Technology Corp. · Apr 1994
K941226 · AIRWATCH MONITOR
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