Cleared Traditional

K932055 - PERCUPUMP II (FDA 510(k) Clearance)

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

K932055 · E-Z-Em, Inc. · Radiology device
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Mar 1995
Decision
692d
Days
Class 2
Risk

K932055 is an FDA 510(k) clearance for the PERCUPUMP II. Classified as Pump, Infusion Or Syringe, Extra-luminal (product code FIH), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 692 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.5820 - the FDA radiology and imaging software oversight 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 Radiology submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K932055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date March 21, 1995
Days to Decision 692 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
585d slower than avg
Panel avg: 107d · This submission: 692d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIH Pump, Infusion Or Syringe, Extra-luminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Radiology devices follow this clearance model.