510(k) · Cleared
ClearedExtension Set Quest Code #3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · FPK Tubing, Fluid Delivery
Cleared on May 14, 1980 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- May 14, 1980
- Review
- 30 days
- Class
- Class II
- Product code
- FPK
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK800825 Extension Set Quest Code #3000Quest Medical, Inc. · 1980
- Descendant · cites it directly · 1 of its ownK151079 Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK162304 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate…Quest Medical, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800825 | Extension Set Quest Code #3000 | Quest Medical, Inc. | 1980 | — |
| +1 | K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | 2015 | 1 |
| +1 | K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV… | Quest Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 FPK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151079 (Quest Medical, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | 1 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K800825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K800825: Extension Set Quest Code #3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K800825
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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