Cleared Traditional

K931173 - PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/A...

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

K931173 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 281
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K931173.
IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
K940897 · Y · Jun 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · Abbott Laboratories · Jun 1994
CONTROL-A-FLO(TM) REGULATOR
K940867 · Baxter Healthcare Corp · May 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · Abbott Laboratories · Mar 1994
EZ ADMINISTRATION SET
K931550 · Y · Jan 1994
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993