Cleared Traditional

K933144 - GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER

K933144 is the FDA 510(k) clearance for GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER by Imed Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K933144 · Imed Corp. · General Hospital
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Oct 1993
Decision
106d
Days
Class 2
Risk

K933144 is an FDA 510(k) clearance for the GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Imed Corp. (San Diego, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Imed Corp. devices

Submission Details

510(k) Number K933144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date October 12, 1993
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 306
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K933144.
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K923224 · Baxter Healthcare Corp · Feb 1994
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IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599
K932544 · Y · Oct 1993
ABBOTT PLUM XL INFUSION PUMP
K931375 · Abbott Laboratories · Sep 1993
INFUSION PUMP
K930781 · Y · Aug 1993
IVAC SYRING PUMP MODEL 770
K925091 · Y · Jul 1993