Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
FDA 510(k) clearance K153193 · decided 2016-08-30
Clearance details
- K-number
- K153193
- Device name
- Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
- Applicant
- Zyno Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-11-03
- Decision date
- 2016-08-30
- Days to decision
- 301 days
- Clearance type
- Abbreviated
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump recall (Z-1811-2024) | OptumHealth Care Solutions LLC | 2024-05-21 |
| Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion Sy recall (Z-1285-2024) | InfuTronix LLC | 2024-03-28 |
| Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus recall (Z-1286-2024) | InfuTronix LLC | 2024-03-28 |
| Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer flui recall (Z-2055-2019) | InfuTronix LLC | 2019-07-23 |