510(k) · Cleared
Recalled · 2007Solution Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Aug 17, 1998 as substantially equivalent to K832284 (Travenol Laboratories, S.A., 1983) after an 88-day review. Its family tree reaches back 1 generation to 1983. 2 of the 16 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 17, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832284 (1983). 14 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK832284 Solution Admin. Set 2C9096 W/10 PVCTravenol Laboratories, S.A. · 1983 · Recalled
- This deviceK981792 Solution Administration SetBaxter Healthcare Corp · 1998
- Descendant · cites it directly · 12 of its ownK120685 Zyno Medical Administration SetZyno Medical, LLC · 2012
- Descendant · 2 generations on · 5 of its ownK151151 U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK232316 DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
- Descendant · 3 generations on · 1 of its ownK230343 ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK173361 IV Administration SetB.Braun Medical, Inc. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 14 · See all- K120685Zyno Medical Administration SetZyno Medical, LLC · 2012 · cites it directly12descendants
- K151151U & U Intravascular Administration SetU&U Medical Technology Co, Ltd. · 2015 · 2 generations on5descendants
- K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024 · 2 generations on1descendant
- K230343ProSeal™ Closed System Administration SetEpic Medical Pte., Ltd. · 2023 · 3 generations on1descendant
- K173361IV Administration SetB.Braun Medical, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832284 | Solution Admin. Set 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983 | 2 |
| 0 (this device) | K981792 | Solution Administration Set | Baxter Healthcare Corp | 1998 | — |
| +1 | K120685 | Zyno Medical Administration Set | Zyno Medical, LLC | 2012 | — |
| +2 | K151151 | U & U Intravascular Administration Set | U&U Medical Technology Co, Ltd. | 2015 | — |
| +2 | K232316 | DEKA Infusion System, DEKA Administration Set | Deka Research and Development | 2024 | — |
| +3 | K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte., Ltd. | 2023 | — |
| +3 | K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 1 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
2 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 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? (2)
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 |
|---|---|---|---|
| * | K832284 | Solution Admin. Set 2C9096 W/10 PVCSummary page 2…et Summary of Technological Characteristics of New Device to Predicate Devices The product is similar to the currently marketed Baxter nitroglycerin set, cleared under K832284A on December 29, 1983. The principal differences between the proposed solution set and the predicate nitroglycerin set include a… | 1983 |
| * | — | Solution Administration Sets with 0.22 Micron Filter Named without a submission number |
What descends from it? (14)
See all 142 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 16, 2007 | Not classified | Z-0619-2007 | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. |
| Feb 16, 2007 | Not classified | Z-0618-2007 | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. |
| Feb 16, 2007 | Not classified | Z-0620-2007 | Other | Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets. |
| Apr 28, 2004 | Not classified | Z-0193-05 | Other | Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device. |
| Jul 16, 2003 | Not classified | Z-1158-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
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.
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The solution adminstration set will be used to administer fluids to a patient’s vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague1rM volumetric infusion pumps.
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/K981792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981792: Solution 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/K981792
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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