# K992072: Bolus Accessory Set

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Sep 15, 1999 after 88 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K884505 (1989). 3 ancestors in all.
21 later devices descend from it; 2 cite it directly.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984638: Paragon Bolus Accessory Set, I-Flow Corp. (1999) Summary page 2.
- K884505: Basal/Bolus Infusors, Baxter Healthcare Corp (1989) Summary page 2.
- K935811: Bolus Dispenser, I-Flow Corp. (1995) 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

## Indications for use
The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative and percutaneous.

Source page: https://510kreport.com/device/K992072
Methodology: https://510kreport.com/methodology