Cleared Special

K992421 - GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 158
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