Cleared Special

K082806 - SPINNING SPIROS, MODEL CH-2000

K082806 is an FDA 510(k) clearance for SPINNING SPIROS, manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K082806

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.

FPA Device Classification - Class 2, Special Controls

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

All 1143
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K082806.
MPS ACACIA POWER INJECTABLE INFUSION SET
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K090134 · C.R. Bard, Inc. · Apr 2009
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K090189 · Icu Medical, Inc. · Apr 2009
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K083482 · Cook Vascular, Inc. · Apr 2009
FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
K082027 · Genesis Bps, LLC · Feb 2009
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
K083765 · Medegen Medical Manufacturing Services · Dec 2008
K082806 · SPINNING SPIROS, MODEL CH-2000
Download PDF FDA Summary Icu Medical, Inc.