510(k) Report

510(k) · Cleared

Cleared

MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI) Keep Vein Open (Kvo) Elastomeric Pumps

K011117510(k) TraditionalCleared Jul 9, 200188-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mps Acacia · MEB Pump, Infusion, Elastomeric

Cleared on Jul 9, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 7 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.

Decided
Jul 9, 2001
Review
88 days
Class
Class II
Product code
MEB
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared, 1 with a Class I recall12016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK011117 MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI)…Mps Acacia · 2001
  2. Descendant · cites it directly · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
  3. Descendant · 2 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
  4. Descendant · 3 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
  5. Descendant · 4 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
  6. Descendant · 4 generations on · 0 of its ownK240624 InfuLifeFirst Medical Source, LLC · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12016: 12024: 22026: 1
2005high 2 (2024) · low 0 (2006)2026

Class I recalls in this family

  • K081905 Accuflow and Accuflux Elastomeric Infusion Pump2 generations on · 2008

Most influential descendants

Showing 5 of 6 · See all
  • K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · cites it directly5descendants
  • K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on4descendants
  • K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 3 generations on3descendants
  • K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 4 generations on0descendants
  • K240624InfuLifeFirst Medical Source, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011117MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI) Keep Vein…Mps Acacia2001—
+1K052451MPS Acacia Medflo Elastomeric PumpMps Acacia2005—
+2K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.2008Class I
+3K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.2016—
+4K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.2026—
+4K240624InfuLifeFirst Medical Source, LLC2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200811
201610
202420
202610
FIG. 1 — Lineage of K011117, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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. #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K052451 (Mps Acacia, 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All MEB devices

MEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEB

2in 2024

2007: 52008: 22009: 12013: 12014: 12016: 12019: 12024: 22026 (partial year): 1
2007high 5 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEB

42in 2007

2007: 42 days median
2007high 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEB

17in 2018

2007: 12008: 32009: 482010: 22011: 8, 1 Class I2013: 2, 1 Class I2018: 17
2007high 48 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · MEB

1,408in 2025

2007: 1102008: 4442009: 7982010: 1,8272011: 2,2652012: 1,9762013: 1,9562014: 2,6952015: 2,9802016: 2,1472017: 1,6532018: 1,4732019: 9742020: 2,7322021: 1,8022022: 1,2882023: 1,2482024: 1,4242025: 1,408
2007high 2,980 (2015) · low 110 (2007)2025

MAUDE reports naming product code MEB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075421110
20082—3444
20091—48798
20100—21,827
20110—8 (1)2,265
20120—01,976
20131—2 (1)1,956
20141—02,695
20150—02,980
20161—02,147
20170—01,653
20180—171,473
20191—0974
20200—02,732
20210—01,802
20220—01,288
20230—01,248
20242—01,424
20250—01,408
20261—0—

More from Mps Acacia

7 FDA decisions under this applicant name. See the company

  • K090809MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
  • K080328MPS Acacia Enteral Feeding TubeMps Acacia · 2008
  • K052946MPS Acacia Nerve Block NeedleMps Acacia · 2005
  • K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
  • K032934MPS Acacia Safeguard Huber DeviceMps Acacia · 2003

Recent decisions in MEB

The MEB category page

  • K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
  • K240624InfuLifeFirst Medical Source, LLC · 2024
  • K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
  • K181360ON-Q* Pump with BolusHalyard Health · 2019
  • K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016

https://510kreport.com/device/K011117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011117: MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI) Keep Vein Open (Kvo) Elastomeric Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011117

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026