Cleared Special

K040802 - HEMOSONIC 200HEMODYNAMIC MONITOR (FDA 510(k) Clearance)

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

K040802 · Arrow Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
30d
Days
Class 2
Risk

K040802 is an FDA 510(k) clearance for the HEMOSONIC 200HEMODYNAMIC MONITOR. Classified as Thin Layer Chromatography, Propoxyphene (product code DPN), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3700 - 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 Arrow Intl., Inc. devices

Submission Details

510(k) Number K040802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date April 28, 2004
Days to Decision 30 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
57d faster than avg
Panel avg: 87d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPN Thin Layer Chromatography, Propoxyphene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3700
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.