Cleared Traditional

K982676 - AIRWATCH II ZONE

K982676 is an FDA 510(k) clearance for AIRWATCH II ZONE, 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 90-day FDA review.

K982676 · Enact Health Management Systems · Anesthesiology device
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Oct 1998
Decision
90d
Days
Class 2
Risk

K982676 is an FDA 510(k) clearance for the AIRWATCH II ZONE. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Enact Health Management Systems (Mountain View, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 90 days - within the typical 510(k) review window.

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 Enact Health Management Systems devices

FDA 510(k) Submission Details - K982676

510(k) Number K982676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1998
Decision Date October 29, 1998
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 37
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K982676.
AIRZONE PEAK FLOWMETER
K982334 · Clement Clarke Intl., Ltd. · Jan 1999
ACCUTRAX, MODEL EPF840
K982995 · Korr Medical Technologies, Inc. · Dec 1998
AIRWATCH II ZONELESS
K982675 · Enact Health Management Systems · Oct 1998
WHISTLE WATCH
K980550 · Harwill Medical (Pty) , Ltd. · Aug 1998
IN-CHECK INSPIRATORY FLOWMETER
K980960 · Clement Clarke Intl., Ltd. · Jun 1998
PEAK FLOW METER MINIMAX
K980443 · The D&T, Inc. · Apr 1998