Cleared Special

ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB (K994039) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K994039 · Abbott Laboratories · General Hospital
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Dec 1999
Decision
23d
Days
Class 2
Risk

K994039 is an FDA 510(k) clearance for the ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 22, 1999 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

Submission Details

510(k) Number K994039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1999
Decision Date December 22, 1999
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K994039.
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories · Jul 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
K000821 · Abbott Laboratories · Mar 2000
HORIZON LIGHT
K994375 · B.Braun Medical, Inc. · Mar 2000
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
K993387 · Baxter Healthcare Corp · Nov 1999
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
PERFUSOR COMPACT
K983005 · B.Braun Medical, Inc. · Feb 1999