Cleared Special

K022869 - SOAKER CATHETER (FDA 510(k) Clearance)

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

K022869 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
22d
Days
Class 2
Risk

K022869 is an FDA 510(k) clearance for the SOAKER CATHETER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on September 20, 2002 after a review of 22 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 I-Flow Corp. devices

Submission Details

510(k) Number K022869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2002
Decision Date September 20, 2002
Days to Decision 22 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
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRN Pump, Infusion
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.

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All 847
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