Cleared Special

K992421 - GUARDIAN LOW PRESSURE ALARM ACCESSORY

K992421 is an FDA 510(k) clearance for GUARDIAN LOW PRESSURE ALARM ACCESSORY, manufactured by Accutron, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 98-day FDA review.

K992421 · Accutron, Inc. · Anesthesiology device
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Oct 1999
Decision
98d
Days
Class 2
Risk

K992421 is an FDA 510(k) clearance for the GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Accutron, Inc. (Phoenix, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Accutron, Inc. devices

FDA 510(k) Submission Details - K992421

510(k) Number K992421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1999
Decision Date October 27, 1999
Days to Decision 98 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 115
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K992421.
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K981530 · Spacelabs Medical, Inc. · Nov 1998