Cleared Traditional

K941418 - INFUSION PUMP

K941418 is an FDA 510(k) clearance for INFUSION PUMP, 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 482-day FDA review.

K941418 · I-Flow Corp. · General Hospital
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Jul 1995
Decision
482d
Days
Class 2
Risk

K941418 is an FDA 510(k) clearance for the INFUSION PUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by I-Flow Corp. (Irvine, US). The FDA issued a Cleared decision on July 18, 1995 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all I-Flow Corp. devices

FDA 510(k) Submission Details - K941418

510(k) Number K941418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1994
Decision Date July 18, 1995
Days to Decision 482 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 129d · This submission: 482d
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 K941418.
BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
K955727 · I-Flow Corp. · Feb 1996
TITAN 20 CC DRIVER
K954059 · I-Flow Corp. · Sep 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028 · I-Flow Corp. · Sep 1995
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664 · Baxter Healthcare Corp · Nov 1994
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382 · Baxter Healthcare Corp · Feb 1993
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
K913658 · Imed Corp. · Mar 1992