Cleared Special

K011096 - ABBOTT ACCLAIM ENCORE

K011096 is an FDA 510(k) clearance for ABBOTT ACCLAIM ENCORE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 21-day FDA review.

K011096 · Abbott Laboratories · General Hospital
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May 2001
Decision
21d
Days
Class 2
Risk

K011096 is an FDA 510(k) clearance for the ABBOTT ACCLAIM ENCORE, MODEL 12237. 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 May 1, 2001 after a review of 21 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

FDA 510(k) Submission Details - K011096

510(k) Number K011096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2001
Decision Date May 01, 2001
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K011096.
STRYKER PAINPUMP PCA
K003543 · Stryker Instruments · Jun 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories · Jun 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · Abbott Laboratories · Apr 2001
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
K003616 · Baxter Healthcare Corp · Dec 2000
INFUSOMAT P
K003029 · B.Braun Medical, Inc. · Dec 2000