Cleared Special

K081992 - DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (FDA 510(k) Clearance)

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

K081992 · Siemens Healthcare Diagnostics, Inc. · Toxicology device
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Aug 2008
Decision
22d
Days
Class 2
Risk

K081992 is an FDA 510(k) clearance for the DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108. Classified as Cyclosporine (product code MKW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 5, 2008 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1235 - the FDA toxicology 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K081992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date August 05, 2008
Days to Decision 22 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MKW Cyclosporine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1235
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 Toxicology devices follow this clearance model.