Cleared Traditional

K081905 - ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP

K081905 is an FDA 510(k) clearance for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUS..., manufactured by Westmed, Inc.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K081905 · Westmed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
12d
Days
Class 2
Risk

K081905 is an FDA 510(k) clearance for the ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Westmed, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on July 15, 2008 after a review of 12 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.

FDA 510(k) Submission Details - K081905

510(k) Number K081905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date July 15, 2008
Days to Decision 12 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
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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

Intertek Testing Services
DANIEL W LEHTONEN

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 - MEB Pump, Infusion, Elastomeric

All 84
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K081905.
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249 · I-Flow, LLC · Feb 2014
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · Mfs - Medical Flow Systems, Ltd. · Aug 2013
MODIFICATION TO AUTOFUSER
K090300 · Ace Medical Us, LLC · Apr 2009
ALPHA INFUSION PUMP, MODEL A200, A450
K071532 · Advanced Infusion, Inc. · Feb 2008
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
K072921 · Symbios Medical Products, LLC · Nov 2007
SMARTBLOCK PAIN PUMP
K072053 · Medical Flow Systems, Ltd. · Nov 2007

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.