# K020862: I-Flow Elastomeric Pump

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Mar 26, 2002 after 8 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896422 (1990). 13 ancestors in all.
19 later devices descend from it; 2 cite it directly.
2 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932740: Homepump NSF, Block Medical, Inc. (1993) Summary page 1.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 1.
- K984502: Nerve Block Infusion Kit, I-Flow Corp. (1999) Summary page 1.
- K991513: Homepump C-Series and Homepump C-Series One-Step Kvo, I-Flow Corp. (1999) Summary page 1.
- K992072: Bolus Accessory Set, I-Flow Corp. (1999) Summary page 1.

## Most influential descendants
- K023098: Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit (2002), 17 descendants of its own
- K033039: Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits (2003), 15 descendants of its own
- K032642: Beeline System (2003), 8 descendants of its own
- K042228: Beeline Motiv, Propolis, Pca (2004), 7 descendants of its own
- K050770: Modification to Accufuser, Accufuser Plus Standard Procedure Kit (2005), 6 descendants of its own

## Recalls of this device
- Aug 19, 2002 · Not classified · Z-0312-04: Slower than expected infusion of medications, such as antibiotics.

## Indications for use
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. 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.

Source page: https://510kreport.com/device/K020862
Methodology: https://510kreport.com/methodology