Cleared Traditional

K883993 - MODIFIED IMED GEMINI PC-1 INFUSION PUMP

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

K883993 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K883993

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
Combination Product No
PCCP Authorized No
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.

FRN Device Classification - Class 2, Special Controls

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 526
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K883993.
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K890062 · Pharmacia Deltec, Inc. · Mar 1989
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K890457 · Medtronic Minimed · Mar 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