# K021130: Specath Central Venous Catheter Kits

- Pathway: 510(k) (Traditional)
- Applicant: Special Medical Co., Ltd.
- Decided: Jan 7, 2003 after 273 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 K900263 (1990). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963257: Peripherally Inserted Medline Catheter, Arrow Intl., Inc. (1997) Summary page 1.
- K900263: Antimicrobial Multi-Lumen Central Venous Catheter, Arrow Intl., Inc. (1990) Summary page 1.
- K971085: Soft Tip Multi-Lumen Central Venous Catheter, B.Braun Medical, Inc. (1997) 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
SPECATHB Central Venous Catheters are intended for the purpose cf providing short term access (less than 30 days) to the vascular system for the infusion of fluids, monitoring of pressures, and/or sampling of blood.

Source page: https://510kreport.com/device/K021130
Methodology: https://510kreport.com/methodology