510(k) · Cleared
Recalled · Class II · 2019Continuflo Solution Set/Secondary Medication 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 Jun 21, 1996 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 21, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 7
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK961225 Continuflo Solution Set/Secondary Medication SetBaxter Healthcare Corp · 1996
- Descendant · cites it directly · 1 of its ownK142011 Solution Set/Extension SetBaxter Healthcare Corporation · 2014
- Descendant · cites it directly · 1 of its ownK130245 Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock…Baxter Healthcare Corp · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK223175 lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK150860 Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K142011Solution Set/Extension SetBaxter Healthcare Corporation · 2014 · cites it directly1descendant
- K130245Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set…Baxter Healthcare Corp · 2013 · cites it directly1descendant
- K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023 · 2 generations on0descendants
- K150860Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961225 | Continuflo Solution Set/Secondary Medication Set | Baxter Healthcare Corp | 1996 | — |
| +1 | K142011 | Solution Set/Extension Set | Baxter Healthcare Corporation | 2014 | — |
| +1 | K130245 | Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with… | Baxter Healthcare Corp | 2013 | 1 |
| +2 | K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023 | — |
| +2 | K150860 | Nitroglycerin Sets with DUO-VENT Spike | Baxter Healthcare Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Current Baxter Solution Administration Sets Named without a submission number | |
| † | K860272 | Solution Administration Sets | 1986 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2019 | Class II | Z-0794-2020 | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. |
| Dec 12, 2019 | Class II | Z-0793-2020 | Device Design | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. |
| Dec 6, 2011 | Not classified | Z-0475-2012 | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| Jul 21, 2011 | Not classified | Z-2920-2011 | Employee error | The Solution Sets are being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded… |
| Dec 15, 2005 | Not classified | Z-0653-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Feb 28, 2005 | Not classified | Z-0845-05 | Other | Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve. |
| Jul 16, 2003 | Not classified | Z-1152-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142011 (Baxter Healthcare Corporation, 2014) has gone furthest, with 1 descendant of its own.
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) | — |
https://510kreport.com/device/K961225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961225: Continuflo Solution Set/Secondary Medication Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961225
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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