Cleared Traditional

K955727 - BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINI...

K955727 is an FDA 510(k) clearance for BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINI..., 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 52-day FDA review.

K955727 · I-Flow Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
52d
Days
Class 2
Risk

K955727 is an FDA 510(k) clearance for the BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET. 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 February 8, 1996 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I-Flow Corp. devices

FDA 510(k) Submission Details - K955727

510(k) Number K955727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date February 08, 1996
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K955727.
PAINBUSTER INFUSION SYSTEM
K980558 · I-Flow Corp. · May 1998
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173 · I-Flow Corp. · Aug 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · Baxter Healthcare Corp · Jul 1997
TITAN 20 CC DRIVER
K954059 · I-Flow Corp. · Sep 1995
TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
K953028 · I-Flow Corp. · Sep 1995
INFUSION PUMP
K941418 · I-Flow Corp. · Jul 1995