Cleared Traditional

K931173 - PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH

K931173 is an FDA 510(k) clearance for PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/A..., manufactured by Imed Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K931173 · Imed Corp. · General Hospital
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Apr 1994
Decision
403d
Days
Class 2
Risk

K931173 is an FDA 510(k) clearance for the PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: 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 Imed Corp. devices

FDA 510(k) Submission Details - K931173

510(k) Number K931173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date April 15, 1994
Days to Decision 403 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
274d slower than avg
Panel avg: 129d · This submission: 403d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 644
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