# K070163: Swabbable Cap, Model 60205

- Pathway: 510(k) (Traditional)
- Applicant: Baxa Corp.
- Decided: Aug 3, 2007 after 198 days
- Product code: ODI (Administration Set Docking Station)
- 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 K981318 (1998). 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)
- K981318: Dual Luer Lock Cap, Baxter Healthcare Corp (1998) Summary page 1.

## Indications for use
The Swabbable Cap provides temporary aseptic closure of the male luer connector of the IV tubing while disconnected from the patient, replacing the need for disposable caps to maintain aseptic procedure. The device is designed to be permanently attached to an IV administration set and used over the life of the administration set.

Source page: https://510kreport.com/device/K070163
Methodology: https://510kreport.com/methodology