Cleared Special

K993907 - VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22 (FDA 510(k) Clearance)

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

K993907 · Agilent Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
19d
Days
Class 2
Risk

K993907 is an FDA 510(k) clearance for the VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22. Classified as Pump, Infusion, Gallstone Dissolution (product code MHD), Class II - Special Controls.

Submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on December 6, 1999 after a review of 19 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 Agilent Technologies, Inc. devices

Submission Details

510(k) Number K993907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1999
Decision Date December 06, 1999
Days to Decision 19 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 128d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHD Pump, Infusion, Gallstone Dissolution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.