# K123874: Interlink System Buretrol Solution Sets, Interlink System Buretrol Solution Sets, Continued, Clearlink System Buretrol S

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 10, 2013 after 24 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K984381 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984381: Buretrol Solution Sets, Baxter Healthcare Corp (1999) Summary page 2.

## Recalls of this device
- Jul 14, 2014 · Class II · Z-2614-2014: Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber
- Jul 14, 2014 · Class II · Z-2615-2014: Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber
- Jul 14, 2014 · Class II · Z-2613-2014: Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber

## Indications for use
The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.

Source page: https://510kreport.com/device/K123874
Methodology: https://510kreport.com/methodology