OTTO™ Disinfecting Cap
FDA 510(k) clearance K252006 · decided 2026-03-27
Clearance details
- K-number
- K252006
- Device name
- OTTO™ Disinfecting Cap
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2026-03-27
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- QBP
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SteriHub™ Disinfecting Device and Protective Cover (K251592) | 1World Vista Medical | 2026-02-11 |
| ACTIV™ Cap (K223914) | Cleansite Medical, Inc. | 2024-04-05 |
| BD PureHub Disinfecting Cap (K193190) | Becton, Dickinson and Company | 2020-11-09 |
| Curos Jet Disinfecting Cap (K200299) | 3M Company | 2020-10-29 |
| CapKlenZ (K192382) | Star Mountain Medical, Inc. | 2020-04-20 |
| SwabTip Male Disinfectant Cap (K190918) | Icu Medical | 2020-03-06 |
| DualCap (K142806) | Catheter Connections, Inc. | 2015-05-22 |
| CUROS RED PORT PROTECTOR (K140657) | Ivera Medical, Inc. | 2014-12-04 |
| DualCap IV Pole Strips(Disinfectant Caps for Male Luers) (K142399) | Catheter Connections, Inc. | 2014-11-19 |
| SWABCAP AND SWABFLUSH (K130975) | Excelsior Medical Corp. | 2013-12-24 |
| CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS (K123967) | Catheter Connections, Inc. | 2013-01-22 |
| CATHETER CONNECTIONS DUALCAP SOLO (K123065) | Catheter Connections, Inc. | 2012-12-14 |
Recalls involving this device
No recalls on record reference this clearance.