510(k) · Cleared
ClearedQ2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 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 Dec 6, 2016 as substantially equivalent to K151079 (Quest Medical, Inc., 2015) and 2 other predicates after a 111-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 6, 2016
- Review
- 111 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003225 (2000). 4 ancestors in all, the oldest K800825 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
- 2 generations backK040385 Multiport Manifold Set with Swabable Valves, Model 9900Quest Medical, Inc. · 2004
- 1 generation backK151079 Q2 Intravenous Adminstration Sets and Extension SetsQuest Medical, Inc. · 2015 · Recalled
- This deviceK162304 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate…Quest Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003225 | Solution Administration Sets with Capless Luer Activated Valve | Baxter Healthcare Corp | 2000 | 18 |
| −2 | K040385 | Multiport Manifold Set with Swabable Valves, Model 9900 | Quest Medical, Inc. | 2004 | — |
| −1 | K151079 | Q2 Intravenous Adminstration Sets and Extension Sets | Quest Medical, Inc. | 2015 | 1 |
| 0 (this device) | 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 |
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? (3)
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 |
|---|---|---|---|
| * | K151079 | Q2 Intravenous Adminstration Sets and Extension SetsSummary page 4…880.5440 CLASS: II PREDICATE DEVICES: Quest Medical, Inc. Q2 Multiport IV Administration Sets and Extension Sets (K151079, K800825) and CheckMate IV Administration Sets and Extension Sets (K040385) DESCRIPTION:… | 2015 |
| * | K800825 | Extension Set Quest Code #3000Summary page 4…0.5440 CLASS: II PREDICATE DEVICES: Quest Medical, Inc. Q2 Multiport IV Administration Sets and Extension Sets (K151079, K800825) and CheckMate IV Administration Sets and Extension Sets (K040385) DESCRIPTION: Sterile,… | 1980 |
| * | K040385 | Multiport Manifold Set with Swabable Valves, Model 9900Summary page 4…IV Administration Sets and Extension Sets (K151079, K800825) and CheckMate IV Administration Sets and Extension Sets (K040385) DESCRIPTION: Sterile, single use non‐pyrogenic intravenous fluid administration sets wh… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following:
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162304: Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 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/K162304
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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