# K052117: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Block, Homepump, Easypump)

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Sep 9, 2005 after 36 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040337 (2004). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040337: I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump), I-Flow Corp. (2004) 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
- K063530: ON-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump (2007), 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

## Recalls of this device
- Feb 11, 2008 · Not classified · Z-2111-2009: I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was includ
- Jan 17, 2006 · Not classified · Z-0584-06: The sterile pack may contain the wrong infusion pump inside.
- Jan 17, 2006 · Not classified · Z-0585-06: The sterile pack may contain the wrong infusion pump inside.

## Indications for use
1. The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural. 2. The I-Flow Elastomeric Pump is also intended 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 may be intraoperative, perineural or percutaneous. 3. The I-Flow Elastomeric Pump is also intended 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.

Source page: https://510kreport.com/device/K052117
Methodology: https://510kreport.com/methodology