# K081905: Accuflow and Accuflux Elastomeric Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Westmed, Inc.
- Decided: Jul 15, 2008 after 12 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896422 (1990). 43 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit, Mckinley Medical, LLC (2005) Summary page 1.
- K062457: Infusor Small Volume Elastomeric Infusion Devices, Baxter Healthcare Corporation (2006) Summary page 1.
- K052451: MPS Acacia Medflo Elastomeric Pump, Mps Acacia (2005) Summary page 1.
- K052117: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump), I-Flow Corp. (2005) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Aug 6, 2014 · Class II · Z-2655-2014: The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are C
- Dec 13, 2013 · Class II · Z-0921-2014: Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medicat
- Oct 20, 2011 · Not classified · Z-0267-2012: Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
- Oct 20, 2011 · Not classified · Z-0268-2012: Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
- Oct 20, 2011 · Not classified · Z-0269-2012: Redi-Flo Elastomeric Infusion Pumps may have a higher flow rate than specified (more than +15%).
- Jul 28, 2011 · Not classified · Z-0081-2012: The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
- Jul 9, 2011 · Class I · Z-0161-2013: Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. The recall was initiated b

## Indications for use
AccuFlo &AccuFlux devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturer's package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Source page: https://510kreport.com/device/K081905
Methodology: https://510kreport.com/methodology