# K991513: Homepump C-Series and Homepump C-Series One-Step Kvo

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Jun 21, 1999 after 52 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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: 1 generation back to K896907 (1990). 2 ancestors in all.
21 later devices descend from it; 3 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.
- K896907: 3M IV Flow Regulator, 3M Company (1990) Summary page 2.

## Most influential descendants
- K020862: I-Flow Elastomeric Pump (2002), 19 descendants of its own
- 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

## Recalls of this device
- Mar 18, 2003 · Not classified · Z-0741-03: Overinfusion due to misassembly.

## Indications for use
The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural. The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggyback infusions. The routes of administration include intravenous, subcutaneous and intramuscular.

Source page: https://510kreport.com/device/K991513
Methodology: https://510kreport.com/methodology