510(k) · Cleared
ClearedQitexio® 4-Way Stopcock (QIT014)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medex · FMG Stopcock, I.V. Set
Cleared on Apr 29, 2025 as substantially equivalent to K123084 (Elcam Medical Acal, 2013) after a 272-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Apr 29, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K862691 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK862691 StopcockRam Development · 1986
- 4 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 3 generations backK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · Recalled
- 2 generations backK111016 Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal · 2011 · Recalled
- 1 generation backK123084 Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP…Elcam Medical Acal · 2013
- This deviceK242255 Qitexio® 4-Way Stopcock (QIT014)Medex · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862691 | Stopcock | Ram Development | 1986 | — |
| −4 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −3 | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | 2 |
| −2 | K111016 | Safeport Manifold (TM) (or Stopcock) | Elcam Medical Acal | 2011 | 12 |
| −1 | K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP… | Elcam Medical Acal | 2013 | — |
| 0 (this device) | K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 FMG? 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 FMG device
- #1 K223499 Three Way Stop Cockscore 6.3 · 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 |
|---|---|---|---|
| * | K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…Summary page 5…ration set Regulatory Class: Class II Product Code: FMG IV. PREDICATE DEVICE INFORMATION Trade/Device Name: Elcam High and Medium Pressure Stopcocks and Manifold (K123084) Common Name: I.V. Set Stopcock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regu… | 2013 |
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 39 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMG
Too few FMG 510(k)s in any year since 2007 to give a median.
Recalls per year · FMG
33in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMG
868in 2025
MAUDE reports naming product code FMG, 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 | 2 | — | 5 | 26 |
| 2008 | 2 | — | 4 | 48 |
| 2009 | 2 | — | 0 | 27 |
| 2010 | 0 | — | 2 | 131 |
| 2011 | 0 | — | 8 | 95 |
| 2012 | 0 | — | 0 | 93 |
| 2013 | 2 | — | 0 | 117 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 96 |
| 2016 | 0 | — | 1 | 148 |
| 2017 | 0 | — | 2 | 114 |
| 2018 | 1 | — | 3 | 164 |
| 2019 | 2 | — | 0 | 400 |
| 2020 | 0 | — | 5 | 284 |
| 2021 | 0 | — | 0 | 245 |
| 2022 | 2 | — | 0 | 280 |
| 2023 | 2 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 935 |
| 2025 | 1 | — | 33 (1) | 868 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient’s vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242255: Qitexio® 4-Way Stopcock (QIT014).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242255
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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