510(k) · Cleared
Recalled · Class II · 2023Q2 Intravenous Adminstration Sets and Extension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Sep 30, 2015 as substantially equivalent to K800825 (Quest Medical, Inc., 1980) and 1 other predicate after a 161-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 30, 2015
- Review
- 161 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003225 (2000). 3 ancestors in all, the oldest K800825 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
- 1 generation backK040385 Multiport Manifold Set with Swabable Valves, Model 9900Quest Medical, Inc. · 2004
- This deviceK151079 Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc. · 2015
- 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 1 of 1 · See all- K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV…Quest Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003225 | Solution Administration Sets with Capless Luer Activated Valve | Baxter Healthcare Corp | 2000 | 18 |
| −1 | K040385 | Multiport Manifold Set with Swabable Valves, Model 9900 | Quest Medical, Inc. | 2004 | — |
| 0 (this device) | K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | 2015 | — |
| +1 | K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV… | Quest Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K800825 | Extension Set Quest Code #3000Summary page 4…Set Product Code: FPA, FPK Regulation Number: 880.5440 Class: II PREDICATE DEVICES: Quest Medical, Inc. Extension Sets (K800825) Quest Medical, Inc. IV Administration Sets (K040385) DESCRIPTION: Sterile, single use no… | 1980 |
| * | K040385 | Multiport Manifold Set with Swabable Valves, Model 9900Summary page 4…lass: II PREDICATE DEVICES: Quest Medical, Inc. Extension Sets (K800825) Quest Medical, Inc. IV Administration Sets (K040385) DESCRIPTION: Sterile, single use non-pyrogenic intravenous fluid administration sets wit… | 2004 |
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 |
|---|---|---|---|
| K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV… | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2023 | Class II | Z-0197-2024 | Material/Component Contamination | For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K162304 (Quest Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K800825.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 administration of intravenous fluids to a patient’s vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump.
Use of a needle-free system may aid in the prevention of needle-stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151079: Q2 Intravenous Adminstration Sets and Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151079
Report an extraction error
Are you the manufacturer?
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