510(k) · Cleared
Recalled · Class II · 2025Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock
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 Apr 13, 2006 as substantially equivalent to K022895 (Medical Device Consultants, Inc., 2002) after a 73-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it. It has been recalled 20 times.
- Decided
- Apr 13, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 20
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862691 (1986). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK862691 StopcockRam Development · 1986
- 1 generation backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- This deviceK060231 Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated…Elcam Medical Acal · 2006
- Descendant · cites it directly · 0 of its ownK211204 SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal · 2022
- Descendant · cites it directly · 0 of its ownK103165 Blood Sampling SetAcacia, Inc. · 2010
- 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 ownK071400 Smartsite StopcockCardinal Health, Alaris Products · 2007
Most influential descendants
Showing 4 of 4 · See all- K211204SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal · 2022 · cites it directly0descendants
- K103165Blood Sampling SetAcacia, Inc. · 2010 · cites it directly0descendants
- K082106Elcam Antimicrobial Closed Stopcocks (DSS and TSS)Elcam Medical Acal · 2008 · cites it directly0descendants
- K071400Smartsite StopcockCardinal Health, Alaris Products · 2007 · 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) | K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated… | Elcam Medical Acal | 2006 | — |
| +1 | K211204 | SafePort (TM) Manifold (or Stopcock) | Elcam Medical Acal | 2022 | — |
| +1 | K103165 | Blood Sampling Set | Acacia, Inc. | 2010 | — |
| +1 | K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS) | Elcam Medical Acal | 2008 | — |
| +1 | K071400 | Smartsite Stopcock | Cardinal Health, Alaris Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2022 | 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 1…PREDICATE DEVICES Elcam's ClosedSwabable Stopcock (or MRVLS) is substantially equivalent to Elcam's Stopcocks and Manifolds cleared under 510(k) number K022895. Elcam Medical Special 510(k) revised Summary April 7, 2006 CONFIDENTIAL Elcam Closed Swabable Stopcock and MR VLS… | 2002 |
What descends from it? (4)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0606-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0608-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0649-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0650-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0607-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0645-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0646-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0647-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0648-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0651-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0708-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Nov 20, 2019 | Class II | Z-0939-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Nov 20, 2019 | Class II | Z-0937-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Feb 2, 2017 | Class II | Z-1869-2017 | Package design/selection | The stopcock was found to have punctures. |
| Jan 8, 2014 | Class II | Z-0987-2014 | Process control | Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets. |
| Mar 27, 2009 | Not classified | Z-1432-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Jun 11, 2008 | Not classified | Z-2205-2008 | Process change control | Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility. |
| Jun 11, 2008 | Not classified | Z-2207-2008 | Process change control | Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility. |
| Jun 11, 2008 | Not classified | Z-2206-2008 | Process change control | Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility. |
| Jun 11, 2008 | Not classified | Z-2208-2008 | Process change control | Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility. |
The 5 latest of 20 recalls; the web page lists all.
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 16.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K211204 (Elcam Medical Acal, 2022) 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 Closed Swabable Stopcock and MRVLS 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060231
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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