510(k) · Cleared
ClearedDynarex Three-Way Stopcock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corporation · FMG Stopcock, I.V. Set
Cleared on Mar 14, 2018 as substantially equivalent to K111016 (Elcam Medical Acal, 2011) after a 230-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Mar 14, 2018
- Review
- 230 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K862691 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK862691 StopcockRam Development · 1986
- 3 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 2 generations backK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · Recalled
- 1 generation backK111016 Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal · 2011 · Recalled
- This deviceK172266 Dynarex Three-Way StopcockDynarex Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862691 | Stopcock | Ram Development | 1986 | — |
| −3 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −2 | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | 2 |
| −1 | K111016 | Safeport Manifold (TM) (or Stopcock) | Elcam Medical Acal | 2011 | 12 |
| 0 (this device) | K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 5 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 |
|---|---|---|---|
| * | K111016 | Safeport Manifold (TM) (or Stopcock)Summary page 4…l Regulation Number: 21 CFR 880.5440 Product Code: FMG Device Class: 2 Predicate Device: K111016 Elcam Medical’s SafePort ManifoldTM (or Stopcock). Regulation Number: 21 CFR 880.5440 Product Code:… | 2011 |
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 32 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111016.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172266: Dynarex Three-Way Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172266
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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