Cleared Special

K082806 - SPINNING SPIROS

K082806 is the FDA 510(k) clearance for SPINNING SPIROS by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Special 510(k) pathway after a 194-day FDA review.

K082806 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
194d
Days
Class 2
Risk

K082806 is an FDA 510(k) clearance for the SPINNING SPIROS, MODEL CH-2000. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 6, 2009 after a review of 194 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K082806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date April 06, 2009
Days to Decision 194 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 129d · This submission: 194d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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.

Regulatory Peers - FPA Set, Administration, Intravascular

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