Cleared Special

GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

K023062 · Abbott Laboratories, Inc. · General Hospital
Sep 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K023062 is an FDA 510(k) clearance for the GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on September 30, 2002, 14 days after receiving the submission on September 16, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K023062 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2002
Decision Date September 30, 2002
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

Similar Devices — FRN Pump, Infusion

All 847
FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
K252015 · Koru Medical Systems, Inc. · Jan 2026
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · Baxter Healthcare Corporation · Jul 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · Baxter Healthcare Corporation · Jul 2025
MRidium 3870 MRI Infusion Pump System (3870)
K242752 · Iradimed Corporation · May 2025
BD Alaris Infusion System with Guardrails Suite MX
K243855 · Carefusion 303, Inc. · Apr 2025
Plum Solo? Precision IV Pump
K242114 · Icu Medical, Inc. · Apr 2025