510(k) · Cleared
Recalled · 2010Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Churchill Medical Systems, Inc. · FPA Set, Administration, Intravascular
Cleared on Jun 12, 2001 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Jun 12, 2001
- Review
- 41 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 9
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011336 Primary Solution Set with Universal Spike, Injection Site and Male…Churchill Medical Systems, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK093271 Extension Set (Standardbore Tubing), Extension Set (Minibore…Victus, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011336 | Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock | Churchill Medical Systems, Inc. | 2001 | — |
| +1 | K093271 | Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV… | Victus, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093271 | Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration… | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 16, 2010 | Not classified | Z-1324-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1322-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1332-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1329-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1319-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1328-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1321-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Nov 16, 2010 | Not classified | Z-1320-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
| Oct 20, 2009 | Not classified | Z-1639-2010 | Process change control | Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093271 (Victus, Inc., 2010) has gone furthest, with 0 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/K011336 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011336: Primary Solution Set with Universal Spike, Injection Site and Male Luer Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011336
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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