510(k) · Cleared
ClearedSolution Set/Extension Set
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 Aug 18, 2014 as substantially equivalent to K811078 (Travenol Laboratories, S.A., 1981) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Aug 18, 2014
- Review
- 25 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K811078 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK811078 Radiation Sterilized Admin. SetTravenol Laboratories, S.A. · 1981 · Recalled
- This deviceK142011 Solution Set/Extension SetBaxter Healthcare Corporation · 2014
- Descendant · cites it directly · 0 of its ownK150860 Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K150860Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811078 | Radiation Sterilized Admin. Set | Travenol Laboratories, S.A. | 1981 | 17 |
| 0 (this device) | K142011 | Solution Set/Extension Set | Baxter Healthcare Corporation | 2014 | — |
| +1 | K150860 | Nitroglycerin Sets with DUO-VENT Spike | Baxter Healthcare Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K811078 | Radiation Sterilized Admin. SetSummary page 5…Device Company Predicate 510(k) Clearance date Radiation Sterilized Administration Sets Baxter Healthcare K811078 July 2, 1981 Modified Solution Administration Sets Baxter Healthcare K961225 June 21, 1996… | 1981 |
| * | K961225 | Continuflo Solution Set/Secondary Medication SetSummary page 5…ate Radiation Sterilized Administration Sets Baxter Healthcare K811078 July 2, 1981 Modified Solution Administration Sets Baxter Healthcare K961225 June 21, 1996 DEVICE DESCRIPTION: The proposed devices, which are the subject of this Special 510(k) premark… | 1996 |
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 |
|---|---|---|---|
| K150860 | Nitroglycerin Sets with DUO-VENT Spike | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
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. 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?
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/K142011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142011: Solution Set/Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142011
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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