Cleared Special

K023318 - I-FLOW ELASTOMERIC PUMP WITH BOLUS

K023318 is an FDA 510(k) clearance for I-FLOW ELASTOMERIC PUMP WITH BOLUS, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Special 510(k) pathway after a 14-day FDA review.

K023318 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
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Oct 2002
Decision
14d
Days
Class 2
Risk

K023318 is an FDA 510(k) clearance for the I-FLOW ELASTOMERIC PUMP WITH BOLUS. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 14 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

FDA 510(k) Submission Details - K023318

510(k) Number K023318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2002
Decision Date October 18, 2002
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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.

Regulatory Peers - MEB Pump, Infusion, Elastomeric

All 32
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K023318.
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · I-Flow Corp. · May 2004
B. BRAUN NERVE BLOCK CATHETER
K030830 · B.Braun Medical, Inc. · Jul 2003
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · I-Flow Corp. · Dec 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · Baxter Healthcare Corp · May 2002
I-FLOW ELASTOMERIC PUMP
K020862 · I-Flow Corp. · Mar 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660 · I-Flow Corp. · Mar 2002