# K130975: Swabcap and Swabflush

- Pathway: 510(k) (Traditional)
- Applicant: Excelsior Medical Corp.
- Decided: Dec 24, 2013 after 260 days
- Product code: QBP (Cap, Device Disinfectant)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K030467 (2003). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083508: Swabcap, Excelsior Medical Corp. (2009) Summary page 6.

## Most influential descendants
- K252006: OTTO™ Disinfecting Cap (2026), 0 descendants of its own
- K190918: SwabTip Male Disinfectant Cap (2020), 0 descendants of its own

## Recalls of this device
- Jun 16, 2025 · Class II · Z-2199-2025: SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab C
- Jun 3, 2025 · Class II · Z-2116-2025: Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from

## Indications for use
The flush syringe is intended for the flushing of IV catheters and IV tubing. SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed. SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

Source page: https://510kreport.com/device/K130975
Methodology: https://510kreport.com/methodology