# K023595: Burette-in Line (150 ML)

- Pathway: 510(k) (Traditional)
- Applicant: Tuta Healthcare Pty Limited
- Decided: Dec 18, 2002 after 51 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: 1 generation back to K984381 (1999). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
1 of 5 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). Our reading of the summary gave K084381, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Baxter Healthcare’s In-Line Buretrol Extension Set”.

## Most influential descendants
- K121511: Maclin Power Intravascular Administration Set (2013), 0 descendants of its own
- K092905: Autostart Burette (2010), 0 descendants of its own
- K032767: Lily Volume Meteric Administration Set, Models IB-2111 and Cib-120ES (2004), 0 descendants of its own

## Indications for use
Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient’s vascular system Through a cannula inserted into a vein.

Source page: https://510kreport.com/device/K023595
Methodology: https://510kreport.com/methodology