510(k) · Cleared
Recalled · Class II · 2025Intravascular Administration Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · FPA Set, Administration, Intravascular
Cleared on Sep 30, 2021 as substantially equivalent to K112893 (Baxter Healthcare Corporation, 2011) after a 294-day review. Its family tree reaches back 2 generations to 2000. 2 of the 7 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 30, 2021
- Review
- 294 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003225 (2000). 4 later devices descend from it, 4 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
- 1 generation backK112893 Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter…Baxter Healthcare Corporation · 2011 · Recalled (Class I)
- This deviceK203609 Intravascular Administration SetsBaxter Healthcare Corporation · 2021
- Descendant · cites it directly · 0 of its ownK243529 Solution Administration SetsBaxter Healthcare Corporation · 2025 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK221121 Volumat Polyethylene I.V. Administration SetFresenius Kabi · 2023
- Descendant · cites it directly · 0 of its ownK220301 Volumat LineFresenius Kabi · 2023
- Descendant · cites it directly · 0 of its ownK220312 Polyfusion IV Administration SetsPoly Medicure Limited · 2023
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K243529Solution Administration SetsBaxter Healthcare Corporation · 2025 · cites it directly0descendants
- K221121Volumat Polyethylene I.V. Administration SetFresenius Kabi · 2023 · cites it directly0descendants
- K220301Volumat LineFresenius Kabi · 2023 · cites it directly0descendants
- K220312Polyfusion IV Administration SetsPoly Medicure Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003225 | Solution Administration Sets with Capless Luer Activated Valve | Baxter Healthcare Corp | 2000 | 18 |
| −1 | K112893 | Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension… | Baxter Healthcare Corporation | 2011 | Class I |
| 0 (this device) | K203609 | Intravascular Administration Sets | Baxter Healthcare Corporation | 2021 | — |
| +1 | K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025 | Class I |
| +1 | K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi | 2023 | — |
| +1 | K220301 | Volumat Line | Fresenius Kabi | 2023 | — |
| +1 | K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K112893 | Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsSummary page 4…Table 1. Predicate Device Device Company Predicate 510(k) Clearance Date Solution Administration Baxter Healthcare K112893 Oct 18, 2011 Sets Corporation DESCRIPTION OF THE DEVICE: The proposed devices consist of I… | 2011 |
| † | K153158 | Solution Administration Sets with 0.2 Micron Filter | 2015 |
| † | K150860 | Nitroglycerin Sets with DUO-VENT Spike | 2015 |
| † | K161323 | Solution Set for Epidural Use | 2016 |
| † | K123868 | Interlink System Lever Lock Cannula with Check Valve, Secondary Medication Sets… | 2013 |
| † | K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | 2017 |
| † | K180739 | Clearlink System Solution Set | 2019 |
What descends from it? (4)
4 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 |
|---|---|---|---|---|
| Aug 29, 2025 | Class II | Z-0193-2026 | Process control | IV sets may leak. |
| Aug 29, 2025 | Class II | Z-0194-2026 | Process control | IV sets may leak. |
| Aug 29, 2025 | Class II | Z-0192-2026 | Process control | IV sets may leak. |
| Aug 8, 2025 | Class II | Z-2594-2025 | Under Investigation by firm | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation. |
| Dec 20, 2024 | Class II | Z-1011-2025 | Process control | Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. |
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.
- K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K243529Solution Administration SetsBaxter Healthcare Corporation · 2025 · Cites it directly · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243529 (Baxter Healthcare Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K112893.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
For the administration of fluids from a container into the patient’s vascular system through a vascular access device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203609: Intravascular Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203609
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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