# K073444: Triton Meidcal Tmed IV-Set

- Pathway: 510(k) (Traditional)
- Applicant: Triton Medical, LLC
- Decided: Aug 18, 2008 after 255 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043235 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043235: Dragon Heart I.V. Set, Dragon Heart Medical Devices Co., Ltd. (2005) Summary page 1.

## Recalls of this device
- Jun 14, 2016 · Class II · Z-2231-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2234-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2235-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2221-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2229-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2225-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2226-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2227-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2233-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2222-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2230-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2224-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2232-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2223-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.
- Jun 14, 2016 · Class II · Z-2228-2016: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

## Indications for use
The Triton Medical TMed IV-Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

Source page: https://510kreport.com/device/K073444
Methodology: https://510kreport.com/methodology