# K024007: Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J

- Pathway: 510(k) (Traditional)
- Applicant: Sunder Biomedical Tech. Co., Ltd.
- Decided: Jul 14, 2003 after 222 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K993691 (2000). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (2000) Summary page 1.

## Most influential descendants
- K070451: Able Central Venous Catheter (2007), 1 descendant of its own
- K193158: ACENT™ Central Venous Catheter (2020), 0 descendants of its own

## Indications for use
The triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion. Patients requiring multiple sites for IV access. Patients lacking useable peripheral IV sites. Patients requiring central venous pressure monitoring. Patients requiring total parenteral nutrition. Patients receiving incompatible medications. Patients requiring multiple infusions of fluids, medications, or chemotherapy. Patients subject to frequent blood sampling or receiving blood transfusions. Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have divergent pH values.

Source page: https://510kreport.com/device/K024007
Methodology: https://510kreport.com/methodology