Cleared Traditional

K944733 - PLUM XL INFUSION PUMP

K944733 is an FDA 510(k) clearance for PLUM XL INFUSION PUMP, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K944733 · Abbott Laboratories · General Hospital
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Feb 1995
Decision
135d
Days
Class 2
Risk

K944733 is an FDA 510(k) clearance for the PLUM XL INFUSION PUMP. 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 February 8, 1995 after a review of 135 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K944733

510(k) Number K944733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date February 08, 1995
Days to Decision 135 days
Submission Type Traditional
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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K944733.
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
K950419 · Imed Corp. · Jun 1995
LIFECARE 175 INFUSER, MODIFICATION
K944190 · Abbott Laboratories · May 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
LOCKBOX
K942161 · Pharmacia Deltec, Inc. · Aug 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994