Cleared Special

HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 (K982619) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K982619 · Hewlett-Packard Co. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
16d
Days
Class 2
Risk

K982619 is an FDA 510(k) clearance for the HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hewlett-Packard Co. devices

Submission Details

510(k) Number K982619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date August 12, 1998
Days to Decision 16 days
Submission Type Special
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
123d faster than avg
Panel avg: 139d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 12
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