# K190918: SwabTip Male Disinfectant Cap

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical
- Decided: Mar 6, 2020 after 332 days
- Product code: QBP (Cap, Device Disinfectant)
- 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: 5 generations back to K030467 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130975: Swabcap and Swabflush, Excelsior Medical Corp. (2013) Summary page 5.

## Indications for use
SwabTip™ is intended for use on ISO male luer connectors as a cover to protect the luer from potential contamination. The SwabTip™ acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabTip™ will disinfect the male luer (30) seconds after application and maintains a disinfected luer surface for up to four days (96 hours) if not removed.

Source page: https://510kreport.com/device/K190918
Methodology: https://510kreport.com/methodology