Cleared Traditional

WINGED INFUSION SET (K885264) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K885264 · E-Z-Em, Inc. · General Hospital
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Jan 1989
Decision
40d
Days
Class 2
Risk

K885264 is an FDA 510(k) clearance for the WINGED INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K885264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1988
Decision Date January 31, 1989
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K885264.
EXTENSION SET W/FLOW REGULATOR
K890489 · Baxter Healthcare Corp · Jun 1989
LOW ADSORPTION ADMINISTRATION SET
K885031 · 3M Company · May 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · Abbott Laboratories · Feb 1989
STANDARD ADMINISTRATION SETS
K885030 · 3M Company · Jan 1989
SAFESITE INJECTION SITE AND BLUNT CANNULA
K883638 · Baxter Healthcare Corp · Sep 1988
EXTENDED LIFE INJECTION SITE
K882007 · Baxter Healthcare Corp · Jun 1988