510(k) · Cleared
Recalled · Class II · 2018Elcam Stopcocks and Manifolds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · FMG Stopcock, I.V. Set
Cleared on Jul 30, 2014 as substantially equivalent to K022895 (Medical Device Consultants, Inc., 2002) after a 77-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 30, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862691 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK862691 StopcockRam Development · 1986
- 1 generation backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- This deviceK141254 Elcam Stopcocks and ManifoldsElcam Medical Acal · 2014
- Descendant · cites it directly · 0 of its ownK223499 Three Way Stop CockM/S Romsons International · 2023
Most influential descendants
Showing 1 of 1 · See all- K223499Three Way Stop CockM/S Romsons International · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862691 | Stopcock | Ram Development | 1986 | — |
| −1 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| 0 (this device) | K141254 | Elcam Stopcocks and Manifolds | Elcam Medical Acal | 2014 | — |
| +1 | K223499 | Three Way Stop Cock | M/S Romsons International | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K022895 | Elcam Stopcocks and ManifoldsSummary page 2…tial equivalence Elcam Stopcocks and manifolds with Safe2 Rotator are substantially equivalent to Elcam stopcocks and manifolds cleared under 5 10O(k) number K022895. This new stopcocks variation has the same indication for use, principle of operation, overall shape, sterilization m… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223499 | Three Way Stop Cock | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2018 | Class II | Z-0155-2022 | Package design/selection | Product has a lack of sterility assurance |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K223499 (M/S Romsons International, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022895.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Elcamn Stopcocks and Manifolds with Safe2 Rotator are indicated for fluid flow directional control and for providing access port(s) for administration of solutions.
Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141254: Elcam Stopcocks and Manifolds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141254
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