Cleared Traditional

K031185 - ABBOTT PLUM A+ INFUSION PUMP WITH A HPL...

K031185 is an FDA 510(k) clearance for ABBOTT PLUM A+ INFUSION PUMP WITH A HPL..., 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 15-day FDA review.

K031185 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
15d
Days
Class 2
Risk

K031185 is an FDA 510(k) clearance for the ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE. 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 April 30, 2003 after a review of 15 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K031185

510(k) Number K031185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date April 30, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Entela, Inc.
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K031185.
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · Stryker Instruments · Jul 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · The Anspach Effort, Inc. · May 2003
MODIFICATION TO STRYKER PAINPUMP2
K030885 · Stryker Instruments · Apr 2003
VISTA BASIC WITH FM SYSTEM
K023189 · B.Braun Medical, Inc. · Mar 2003
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · Mettler Electronics Corp. · Feb 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.