510(k) · Cleared
ClearedMultibolus II Disposable Pain Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mfs - Medical Flow Systems, Ltd. · MEB Pump, Infusion, Elastomeric
Cleared on Aug 14, 2013 as substantially equivalent to K051253 (Baxter Healthcare Corp, 2005) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Aug 14, 2013
- Review
- 105 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K040337 (2004). 6 ancestors in all, the oldest K002739 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK040337 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)I-Flow Corp. · 2004
- 2 generations backK052117 I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump…I-Flow Corp. · 2005 · Recalled
- 1 generation backK063530 ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump…I-Flow Corp. · 2007 · Recalled
- This deviceK131247 Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040337 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump) | I-Flow Corp. | 2004 | — |
| −2 | K052117 | I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump) | I-Flow Corp. | 2005 | 3 |
| −1 | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse… | I-Flow Corp. | 2007 | 3 |
| 0 (this device) | K131247 | Multibolus II Disposable Pain Management System | Mfs - Medical Flow Systems, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…Summary page 4…Multiliolus 1PM Multirate Infusor ON-Q Pump -New Device - 510(k) no. K051253 510(k) no. K(063530 Intend of use The Multi~lolus 1PTM is The intended use of t… | 2005 |
| * | K063530 | ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…Summary page 1…SV) with PCM, cleared under 5 10(k) number K(051253 and; 3.2 I-Flow Corporation ON-Q Pump, cleared under 5 10(k) number K(063530. .................................................................................................................… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K051253.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131247: Multibolus II Disposable Pain Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131247
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026