510(k) · Cleared
Recalled · 2005Baxter Solution Administration Sets
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 Jul 20, 1993 after a 302-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 20, 1993
- Review
- 302 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 5
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK924721 Baxter Solution Administration SetsBaxter Healthcare Corp · 1993
- Descendant · cites it directly · 2 of its ownK023039 Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 2002
- Descendant · cites it directly · 1 of its ownK041496 Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005
- Descendant · 2 generations on · 0 of its ownK083349 Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009
Most influential descendants
Showing 3 of 3 · See all- K023039Blood/Solution Administration Set, Model 33.015Tuta Healthcare Pty Limited · 2002 · cites it directly2descendants
- K041496Pentatrasfu Blood Transfusion SetsPentaferte S.P.A · 2005 · cites it directly1descendant
- K083349Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924721 | Baxter Solution Administration Sets | Baxter Healthcare Corp | 1993 | — |
| +1 | K023039 | Blood/Solution Administration Set, Model 33.015 | Tuta Healthcare Pty Limited | 2002 | — |
| +1 | K041496 | Pentatrasfu Blood Transfusion Sets | Pentaferte S.P.A | 2005 | — |
| +2 | K083349 | Blood Transfusion Set | Shan Dong Wei Gao Group Medical Polymer Products | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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 15, 2005 | Not classified | Z-0646-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Jul 16, 2003 | Not classified | Z-1154-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1165-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Jul 16, 2003 | Not classified | Z-1155-03 | Other | There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process. |
| Oct 17, 2002 | Not classified | Z-0516-03 | Other | The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023039 (Tuta Healthcare Pty Limited, 2002) has gone furthest, with 2 descendants 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/K924721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924721: Baxter Solution 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/K924721
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026