# K252006: OTTO™ Disinfecting Cap

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Mar 27, 2026 after 273 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
OTTO is intended for use on swabbable needlefree connectors as a cover to protect the needlefree connectors from potential contamination. OTTO acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. OTTO will disinfect the connector thirty (30) seconds after application and maintains a disinfected connector surface for up to seven (7) days if not removed.

Source page: https://510kreport.com/device/K252006
Methodology: https://510kreport.com/methodology