Cleared Traditional

K040337 - I-FLOW ELASTOMERIC PUMP (ON-Q

K040337 is an FDA 510(k) clearance for I-FLOW ELASTOMERIC PUMP (ON-Q, manufactured by I-Flow Corp.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K040337 · I-Flow Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2004
Decision
103d
Days
Class 2
Risk

K040337 is an FDA 510(k) clearance for the I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP). 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 May 24, 2004 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all I-Flow Corp. devices

FDA 510(k) Submission Details - K040337

510(k) Number K040337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date May 24, 2004
Days to Decision 103 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K040337.
SEMPERFLO INFUSION SYSTEM
K052999 · Ethicon, Inc. · Mar 2006
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005
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
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · I-Flow Corp. · Oct 2002