510(k) · Cleared
ClearedBacstop
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 May 11, 2006 as substantially equivalent to K022895 (Medical Device Consultants, Inc., 2002) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- May 11, 2006
- Review
- 155 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861563 (1986). 4 ancestors in all, the oldest K862691 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK861563 Vitaguard Percutaneous Infection Control KitVitaphore Corp. · 1986
- 1 generation backK954970 Stopcock & Luer Lock PlugMedex, Inc. · 1996 · Recalled
- This deviceK053405 BacstopElcam Medical Acal · 2006
- Descendant · cites it directly · 0 of its ownK082106 Elcam Antimicrobial Closed Stopcocks (DSS and TSS)Elcam Medical Acal · 2008
- Descendant · cites it directly · 0 of its ownK073396 Antimicrobial Ultrasite Value, Ultrasite AGB.Braun Medical, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861563 | Vitaguard Percutaneous Infection Control Kit | Vitaphore Corp. | 1986 | — |
| −1 | K954970 | Stopcock & Luer Lock Plug | Medex, Inc. | 1996 | 1 |
| 0 (this device) | K053405 | Bacstop | Elcam Medical Acal | 2006 | — |
| +1 | K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS) | Elcam Medical Acal | 2008 | — |
| +1 | K073396 | Antimicrobial Ultrasite Value, Ultrasite AG | B.Braun Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 |
|---|---|---|---|
| * | K022895 | Elcam Stopcocks and ManifoldsSummary page 3…Elcam's Antimicrobial Stopcock is substantially equivalent to Elcam's conventional legally marketed Stopcock cleared by 510(k) number K022895 and to Medex's legally marketed Antimicrobial Stopcock cleared by 5 10(k) number K954970. Elc… | 2002 |
| * | K954970 | Stopcock & Luer Lock PlugSummary page 1…e, it is substantially equivalent to Medex's MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug cleared under 510(k) number 1K954970. Elcam Medical 510(k) November 28, 2005 CONFIDENTIAL Elcamn Antimicrobial Stopcock [or Manif… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K082106 (Elcam Medical Acal, 2008) 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.
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 Stopcock [or Manifold] is 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.
Elcam Antimicrobial Stopcock [or Manifold] has 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/K053405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053405: Bacstop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053405
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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