510(k) · Cleared
ClearedElcam Antimicrobial Closed Stopcocks (DSS and TSS)
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 Oct 2, 2008 as substantially equivalent to K053405 (Elcam Medical Acal, 2006) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Oct 2, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K862691 (1986). 6 ancestors in all. 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 backK060231 Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…Elcam Medical Acal · 2006 · Recalled
- This deviceK082106 Elcam Antimicrobial Closed Stopcocks (DSS and TSS)Elcam Medical Acal · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862691 | Stopcock | Ram Development | 1986 | — |
| −2 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −1 | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated… | Elcam Medical Acal | 2006 | 20 |
| 0 (this device) | K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS) | Elcam Medical Acal | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K053405 | BacstopSummary page 1…sed Stopcocks (DSS and TSS) are substantially equivalent to Elcam's AntimicrobialStopcock (B-Stop) cleared under 5 10(k) number K053405 and to Elcam's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock)… | 2006 |
| * | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-StopcockSummary page 1…cam's Closed Swabable Stopcock and MRVLS (Minimal Residual Volume Luer-activated Swabable stopcock) cleared under 510(k) number K060231. ................................................................................................................................… | 2006 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K053405.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Elcam Antimicrobial Closed Stopcocks (DSS and TSS) 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.
Both configurations have a feature of an antimicrobial agent using a compound containing silver.
The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.
The device is NOT intended to be used as a treatment for patient infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082106: Elcam Antimicrobial Closed Stopcocks (DSS and TSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082106
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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