510(k) · Cleared
Recalled · Class I · 2024Halo 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 Oct 17, 2014 as substantially equivalent to K982839 (Sims Deltec, Inc., 1998) and 3 other predicates after a 200-day review. Its family tree reaches back 3 generations to 1983. 4 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Oct 17, 2014
- Review
- 200 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2 (2 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K832284 (1983). 12 ancestors in all. 1 later device descends from it, 1 citing it directly. 4 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- 2 generations backK981792 Solution Administration SetBaxter Healthcare Corp · 1998 · Recalled
- 1 generation backK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- This deviceK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014
- Descendant · cites it directly · 0 of its ownK153193 Halo II Ambulatory Infusion System (also with trade names Nimbus II…Zyno Medical, LLC · 2016 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| −2 | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | 5 |
| −1 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| 0 (this device) | K140783 | Halo Ambulatory Infusion System | Zyno Medical, LLC | 2014 | — |
| +1 | K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory… | Zyno Medical, LLC | 2016 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K982839 | Cadd-Legacy Pca Ambulatory Infusion System, Model 6300Summary page 4…mp, product code MEA (21 CFR 880.5725); and Administration Set, product code FPA (21 CFR 880.5440) Predicate Device: CADD-Legacy PCA Model 6300 (K982839) ambIT Continuous Ambulatory Infusion Pump (K033325) CADD-Solis VIP Ambulatory Infusion… | 1998 |
| * | K033325 | Ambit Continuous Ambulatory Infusion PumpSummary page 4…ration Set, product code FPA (21 CFR 880.5440) Predicate Device: CADD-Legacy PCA Model 6300 (K982839) ambIT Continuous Ambulatory Infusion Pump (K033325) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K12… | 2003 |
| * | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety SoftwareSummary page 4…DD-Legacy PCA Model 6300 (K982839) ambIT Continuous Ambulatory Infusion Pump (K033325) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K120685) I. INTENDED USE The Halo Ambulatory Infusion System is in… | 2013 |
| * | K120685 | Zyno Medical Administration SetSummary page 4…ontinuous Ambulatory Infusion Pump (K033325) CADD-Solis VIP Ambulatory Infusion Pump (K111275) Zyno Medical Administration Set (K120685) I. INTENDED USE The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion… Class I | 2016 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
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.
- 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
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 7 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K153193 (Zyno Medical, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982839.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 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. The device is intended for subcutaneous, perineural, epidural and intravenous
infusion. The device is intended for 240 hours or1500mL of infusion, whichever limit is reached first.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140783: Halo 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/K140783
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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