510(k) · Cleared
ClearedQ2 Low Pressure Power Injection Extension Set
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 Mar 8, 2017 as substantially equivalent to K140831 (Care Fusion, 2014) after a 154-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 8, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942988 (1995). 17 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 6 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 5 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 4 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 3 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 2 generations backK132413 MZ1000Care Fusion · 2013
- 1 generation backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- This deviceK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK182897 Velano Vascular Q2 Extension SetVelano Vascular · 2019
- Descendant · 2 generations on · 2 of its ownK200439 Velano ExT Extension SetVelano Vascular · 2021
- Descendant · 3 generations on · 0 of its ownK251257 nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with…Np Medical · 2025
- Descendant · 3 generations on · 0 of its ownK221518 NP Medical nCompass Extension Set with Stabilizing BaseNp Medical · 2022
Most influential descendants
Showing 4 of 4 · See all- K182897Velano Vascular Q2 Extension SetVelano Vascular · 2019 · cites it directly3descendants
- K200439Velano ExT Extension SetVelano Vascular · 2021 · 2 generations on2descendants
- K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…Np Medical · 2025 · 3 generations on0descendants
- K221518NP Medical nCompass Extension Set with Stabilizing BaseNp Medical · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −6 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −5 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −4 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −3 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −1 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| 0 (this device) | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
| +1 | K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019 | — |
| +2 | K200439 | Velano ExT Extension Set | Velano Vascular | 2021 | — |
| +3 | K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle… | Np Medical | 2025 | — |
| +3 | K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K140831 | Maxzero Extension Set with Needless ConnectorSummary page 4…880.5440 CLASS: II PREDICATE DEVICE: Carefusion MaxPlus® Pressure Rated Extension Set with removable clear needleless connector (K140831) REFERENCE DEVICE: Quest Medical Inc. Q2® Multiport IV Administration Sets and Extension Sets an… | 2014 |
| † | K162304 | Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV… | 2016 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182897 | Velano Vascular Q2 Extension Set | 2019 | 3 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 17 ancestors have a recall of any class.
- Of its descendants, K182897 (Velano Vascular, 2019) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K140831.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.
Non Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162804: Q2 Low Pressure Power Injection Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162804
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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