Cleared Traditional

K883993 - MODIFIED IMED GEMINI PC-1 INFUSION PUMP

K883993 is the FDA 510(k) clearance for MODIFIED IMED GEMINI PC-1 INFUSION PUMP by Imed Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883993 · Imed Corp. · General Hospital
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Dec 1988
Decision
90d
Days
Class 2
Risk

K883993 is an FDA 510(k) clearance for the MODIFIED IMED GEMINI PC-1 INFUSION PUMP. 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 December 19, 1988 after a review of 90 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 K883993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date December 19, 1988
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 K883993.
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K891583 · Y · Jun 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
LIFECARE MICRO PUMP
K883796 · Abbott Laboratories · Feb 1989
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988
BIOSEARCH 3600 ENTRI FEEDING PUMP
K883587 · Biosearch Medical Products, Inc. · Nov 1988