510(k) · Cleared
ClearedThree Way Stop Cock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M/S Romsons International · FMG Stopcock, I.V. Set
Cleared on Jul 21, 2023 as substantially equivalent to K141254 (Elcam Medical Acal, 2014) after a 242-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 21, 2023
- Review
- 242 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862691 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK862691 StopcockRam Development · 1986
- 2 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 1 generation backK141254 Elcam Stopcocks and ManifoldsElcam Medical Acal · 2014 · Recalled
- This deviceK223499 Three Way Stop CockM/S Romsons International · 2023
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K141254 | Elcam Stopcocks and ManifoldsSummary page 4…80.5440 Product Code: FMG Device Class: Class II Classification Panel: General Hospital 5.4 Predicate Device [21 CFR 807.92(a) (3)] K141254; Elcam Medical Stopcocks and manifolds with Safe2 Rotator by Elcam Medical ACAL, Israel.… | 2014 |
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 37 years and passes through 4 companies; a new generation was cleared every 11.8 years on median.
- 2 of the 3 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. 2023, 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?
3-way stopcocks are indicated for venous or arterial use, as IV add-on devices used for simultaneous infusions, intermittent drug injections, for central venous pressure measurements, and as arterial add-on devices used for invasive pressure measurements, flushing with normal saline.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223499: Three Way Stop Cock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223499
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