# K052451: MPS Acacia Medflo Elastomeric Pump

- Pathway: 510(k) (Traditional)
- Applicant: Mps Acacia
- Decided: Dec 8, 2005 after 92 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: 9 generations back to K896422 (1990). 33 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011117: MPS Acacia Medflo Infusion (LI) and MPS Acacia Medflo Infusion (LI) Keep Vein Open (Kvo) Elastomeric Pumps, Mps Acacia (2001) Summary page 1.
- K003476: MPS Acacia Pain Kit, Mps Acacia (2001) Summary page 1.
- K020251: Paragon Infusion System, I-Flow Corp. (2002) Summary page 1.
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit, Mckinley Medical, LLC (2005) Summary page 1.

## Most influential descendants
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (2026), 0 descendants of its own
- K240624: InfuLife (2024), 0 descendants of its own
- K242152: SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (2024), 0 descendants of its own

## Indications for use
The MPS Acacia MedFlo Elastomeric Pump is indicated for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy, and pain management. Routes of administration include intravenous, intra-arterial, subcutaneous, intramuscular, and epidural. The keep vein open (KVO) version provides a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The MedFlo Elastomeric pump may also include an optional Y-site at the distal end of the administration set to allow piggyback infusions, and an optional bolus mechanism intended for patient controlled infusion. The MPS Acacia MedFlo Elastomeric Pump is also indicated for continuous and/or intermittent delivery of medication, such as local anesthetics or narcotics, to surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and pain management. Routes of administration include intraoperative, perineural, and percutaneous. The MPS Acacia MedFlo Elastomeric Pump is also indicated to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. The MPS Acacia MedFlo Elastomeric Pump is disposable and single use only.

Source page: https://510kreport.com/device/K052451
Methodology: https://510kreport.com/methodology