510(k) · Cleared
Recalled · Class I · 2025Z-800 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 Jun 12, 2013 as substantially equivalent to K100705 (Zyno Medical, LLC, 2010) after a 90-day review. Its family tree reaches back 2 generations to 1995. 3 of the 6 devices in its family, counting itself, have a Class I recall. It has been recalled 9 times, including 5 Class I recalls.
- Decided
- Jun 12, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 9 (5 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950766 (1995). 5 ancestors in all. No later device cites it as a predicate yet. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK950766 Sigma 8000 and Sigma 8002Sigma Intl. General Medical Apparatus, Inc. · 1995
- 1 generation backK100705 Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010 · Recalled (Class I)
- This deviceK130690 Z-800 Infusion SystemZyno Medical, LLC · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950766 | Sigma 8000 and Sigma 8002 | Sigma Intl. General Medical Apparatus, Inc. | 1995 | — |
| −1 | K100705 | Zyno Z-800 Infusion System Model Z-800 | Zyno Medical, LLC | 2010 | Class I |
| 0 (this device) | K130690 | Z-800 Infusion System | Zyno Medical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 1 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
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.
3 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? (1)
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 |
|---|---|---|---|
| * | K100705 | Zyno Z-800 Infusion System Model Z-800Summary page 1…tric Infusion Pump Classification Name: Infusion Pump Product code: FRN 880.5725 Establishment Registration Number: 3006575795 Predicate Devices Z-800 Infusion System (K100705) Intended Use K300 JUN 1 2 2013 The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, b… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2025 | Class I | Z-1867-2025 | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. |
| May 7, 2025 | Class I | Z-1868-2025 | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. |
| May 7, 2025 | Class I | Z-1865-2025 | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. |
| May 7, 2025 | Class I | Z-1866-2025 | Software design (manufacturing process) | Unreleased software versions were installed on distributed devices without verification or validation. |
| Oct 18, 2024 | Class II | Z-0506-2025 | Device Design | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. |
| Sep 30, 2024 | Class III | Z-0523-2025 | Software design (manufacturing process) | For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024. |
| Sep 13, 2024 | Class I | Z-0005-2025 | Process change control | There is a defect in the air-in-line software algorithm. |
| Jun 4, 2024 | Class II | Z-2263-2024 | Process control | Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having insufficient or no… |
| Dec 20, 2023 | Class II | Z-1183-2024 | Software design | When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in… |
The 5 latest of 9 recalls; the web page lists all.
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.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
- 3 of the 5 ancestors have a recall of any class; 2 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. 2013, 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 Z-800 Infusion system is intended to provide
intravenous infusion of parenteral fluids, blood and blood products to a patient
under the direction or supervision of physician or other certified health care
professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130690: Z-800 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/K130690
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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