Cleared Traditional

K960512 - GEMINI PC-ITX

K960512 is an FDA 510(k) clearance for GEMINI PC-ITX, 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 290-day FDA review.

K960512 · Imed Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
290d
Days
Class 2
Risk

K960512 is an FDA 510(k) clearance for the GEMINI PC-ITX. 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 November 21, 1996 after a review of 290 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K960512

510(k) Number K960512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1996
Decision Date November 21, 1996
Days to Decision 290 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 129d · This submission: 290d
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 694
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K960512.
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K965230 · Abbott Mfg., Inc. · Jul 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · Bio-Tek Instruments, Inc. · Feb 1997
DISETRONIC D-MODEM
K961975 · Disetronic Medical Systems · Jan 1997
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
K962709 · Sigma Intl. · Oct 1996
CADD-PRIZM MODEL 6100 PUMP
K960826 · Sims Deltec, Inc. · Aug 1996
MODEL 1200 ABMULATORY INFUSION PUMP
K961263 · Patient Solutions, Inc. · Aug 1996
K960512 · GEMINI PC-ITX
Download PDF FDA Summary Imed Corp.