510(k) · Cleared
Recalled · Class I · 2024Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zyno Medical, LLC · FRN Pump, Infusion
Cleared on Aug 30, 2016 as substantially equivalent to K140783 (Zyno Medical, LLC, 2014) and 2 other predicates after a 301-day review. Its family tree reaches back 4 generations to 1983. 4 of the 14 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Aug 30, 2016
- Review
- 301 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 5 (3 Class I)
- Predicates
- 3
Its longest line of descent runs back 4 generations to K832284 (1983). 13 ancestors in all. No later device cites it as a predicate yet. 4 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 3 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 2 generations backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- 1 generation backK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
- This deviceK153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II…Zyno Medical, LLC · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −3 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −2 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| −1 | K140783 | Halo Ambulatory Infusion System | Zyno Medical, LLC | 2014 | Class I |
| 0 (this device) | K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory… | Zyno Medical, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 1 |
| 2013 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140783 | Halo Ambulatory Infusion SystemSummary page 4…II Panel: 80 General Hospital Product codes: FRN, MEA, FPA Predicate Device: Halo Ambulatory Infusion System (K140783) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K… | 2014 |
| * | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSummary page 4…ital Product codes: FRN, MEA, FPA Predicate Device: Halo Ambulatory Infusion System (K140783) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K120685) I. INDICATIONS FOR USE The Halo II ambulatory infusion s… | 2013 |
| * | K120685 | Zyno Medical Administration SetSummary page 4…Halo Ambulatory Infusion System (K140783) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K120685) I. INDICATIONS FOR USE The Halo II ambulatory infusion system is intended to deliver medications and/or fluids to a pati… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2024 | Class I | Z-1811-2024 | Device Design | Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or… |
| Feb 21, 2024 | Class I | Z-1285-2024 | Device Design | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump… |
| Feb 21, 2024 | Class I | Z-1286-2024 | Device Design | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump… |
| Oct 19, 2021 | Class II | Z-0832-2022 | Employee error | An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients. |
| May 28, 2019 | Class II | Z-2055-2019 | Employee error | Potential for tube leakage |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K111275Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSmiths Medical Asd, Inc. · 2013 · Direct predicate · ◆ in the 2013 ancestors bar of FIG. 15 Class I recalls
- K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 8 of the 13 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction
or supervision of physician or other certified healthcare professional in clinical or nonclinical environments, such as
homes. The device is intended for subcutaneous, percutaneous, perineural, epidural and intravenous infusion, including
but not limited to patient controlled analgesia (PCA) delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153193: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153193
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026