Cleared Traditional

K131247 - MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131247 · Mfs - Medical Flow Systems, Ltd. · General Hospital
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Aug 2013
Decision
105d
Days
Class 2
Risk

K131247 is an FDA 510(k) clearance for the MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Mfs - Medical Flow Systems, Ltd. (Shlomi, IL). The FDA issued a Cleared decision on August 14, 2013 after a review of 105 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 Mfs - Medical Flow Systems, Ltd. devices

Submission Details

510(k) Number K131247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date August 14, 2013
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - MEB Pump, Infusion, Elastomeric

All 87
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