# K131247: Multibolus II Disposable Pain Management System

- Pathway: 510(k) (Traditional)
- Applicant: Mfs - Medical Flow Systems, Ltd.
- Decided: Aug 14, 2013 after 105 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040337 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051253: Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with and Without PCM), Baxter Healthcare Corp (2005) Summary page 4.
- K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump, I-Flow Corp. (2007) Summary page 1.

## Indications for use
The MUltiBolus JJTM is intended to provide intermittent delivery of medication on patient demand, using patient control module allowing bolus doses, at relatively rapid velocity in parallel to a continuous basal flow or without continuous basal flow, to/or around surgical wound site and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative. periiieural, percutaneous. subcutaneous, intramuscular and epidural.

Source page: https://510kreport.com/device/K131247
Methodology: https://510kreport.com/methodology