510(k) K153193 ยท FRN Pump, Infusion
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
| Applicant | Zyno Medical, LLC, Natick MA, US |
| Decision | Substantially Equivalent, Aug 30, 2016 |
| Received | Nov 3, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K153193
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2024 | OptumHealth Care Solutions LLC Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump Open, Classified |
FRN | None listed |
| Mar 28, 2024 | InfuTronix LLC Nimbus Administration Set;
Nimbus Flex;
Nimbus PainPro (a.k.a. Halo Ambulatory Infusion
System);
Catalog Number IT1025. Ambulatory Infusion Pump and components Open, Classified |
FRN | None listed |
| Mar 28, 2024 | InfuTronix LLC Nimbus II Infusion System;
Nimbus II PainPRO IT1053;
Nimbus II Flex IT1062;
Nimbus II Plus IT1078;
Nimbus II EpiD IT1124;
Nimbus II EMS IT1063;
Ambulatory Infusion Pump and components Open, Classified |
FRN | None listed |
| Oct 19, 2021 | InfuTronix LLC Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Open, Classified |
FRN | None listed |
| Jul 23, 2019 | InfuTronix LLC Nimbus Administration Set, REF HS-004, UDI # 00817170020031
Product Usage:
Administer fluids/medication from a container to a patient through a needle or a catheter. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.