510(k) · Cleared
Recalled · Class II · 2019Zyno Medical Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zyno Medical, LLC · FPA Set, Administration, Intravascular
Cleared on Jan 23, 2014 as substantially equivalent to K120685 (Zyno Medical, LLC, 2012) after a 135-day review. Its family tree reaches back 3 generations to 1983. It has been recalled 6 times.
- Decided
- Jan 23, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 3 generations to K832284 (1983). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK132841 Zyno Medical Administration SetZyno Medical, LLC · 2014
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) | K132841 | Zyno Medical Administration Set | Zyno Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 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.
Planning a device in FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K120685 | Zyno Medical Administration SetSummary page 3…f 3 testing isthat the testing data demonstrated that the device is as safe, as effective, and performs as well as the legally marketed device cleared in K 120685. IV. CLINICAL STUDY H-uman clinical Studies were deemed unnecessary to evaluate the safety or effectiveness of… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2019 | Class II | Z-2058-2019 | Process control | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of… |
| May 29, 2019 | Class II | Z-2059-2019 | Process control | Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of… |
| Jul 29, 2016 | Class II | Z-2896-2016 | Process control | Administration Set potential filter leaking |
| Jul 29, 2016 | Class II | Z-2893-2016 | Process control | Administration Set potential filter leaking |
| Jul 29, 2016 | Class II | Z-2895-2016 | Process control | Administration Set potential filter leaking |
| Jul 29, 2016 | Class II | Z-2894-2016 | Process control | Administration Set potential filter leaking |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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.
- 2 of the 5 ancestors have a recall of any class.
- 5 other devices also cite its predicate K120685.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle
or a catheter inserted into a vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132841: Zyno Medical Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132841
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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