Cleared Traditional

K980550 - WHISTLE WATCH

K980550 is an FDA 510(k) clearance for WHISTLE WATCH, manufactured by Harwill Medical (Pty) , Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K980550 · Harwill Medical (Pty) , Ltd. · Anesthesiology device
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Aug 1998
Decision
196d
Days
Class 2
Risk

K980550 is an FDA 510(k) clearance for the WHISTLE WATCH. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Harwill Medical (Pty) , Ltd. (Crofton, US). The FDA issued a Cleared decision on August 27, 1998 after a review of 196 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 Harwill Medical (Pty) , Ltd. devices

FDA 510(k) Submission Details - K980550

510(k) Number K980550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1998
Decision Date August 27, 1998
Days to Decision 196 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
56d slower than avg
Panel avg: 140d · This submission: 196d
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 K980550.
ACCUTRAX, MODEL EPF840
K982995 · Korr Medical Technologies, Inc. · Dec 1998
AIRWATCH II ZONELESS
K982675 · Enact Health Management Systems · Oct 1998
AIRWATCH II ZONE
K982676 · Enact Health Management Systems · Oct 1998
IN-CHECK INSPIRATORY FLOWMETER
K980960 · Clement Clarke Intl., Ltd. · Jun 1998
PEAK FLOW METER MINIMAX
K980443 · The D&T, Inc. · Apr 1998
PEAK FLOW METER
K970507 · Intl. Medical, Inc. · Jun 1997