# K023318: I-Flow Elastomeric Pump with Bolus

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Oct 18, 2002 after 14 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K896422 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020862: I-Flow Elastomeric Pump, I-Flow Corp. (2002) Summary page 1.

## Recalls of this device
- May 8, 2012 · Class I · Z-2253-2012: It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lower

## Indications for use
1. The 1-Flow Elastomeric Pump with Bolus 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, subcutaneous, intramuscular and epidural. 2 The I-Flow Elastomeric Pump with Bolus 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.

Source page: https://510kreport.com/device/K023318
Methodology: https://510kreport.com/methodology