510(k) · Cleared
Recalled · 2011Stopcock Manifold Gangs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FMG Stopcock, I.V. Set
Cleared on Aug 28, 1996 after a 58-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 14 times.
- Decided
- Aug 28, 1996
- Review
- 58 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 14
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK962581 Stopcock Manifold GangsBaxter Healthcare Corp · 1996
- Descendant · cites it directly · 1 of its ownK130245 Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock…Baxter Healthcare Corp · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK223175 lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023
- Descendant · cites it directly · 0 of its ownK982368 Manifold with Extension SetInterpore Cross Intl. · 1998
Most influential descendants
Showing 3 of 3 · See all- K130245Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set…Baxter Healthcare Corp · 2013 · cites it directly1descendant
- K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023 · 2 generations on0descendants
- K982368Manifold with Extension SetInterpore Cross Intl. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962581 | Stopcock Manifold Gangs | Baxter Healthcare Corp | 1996 | — |
| +1 | K130245 | Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with… | Baxter Healthcare Corp | 2013 | 1 |
| +2 | K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023 | — |
| +1 | K982368 | Manifold with Extension Set | Interpore Cross Intl. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Medex, Inc. Ultra® Stopcock Named without a submission number | |
| * | — | Medex, Inc. Stopcock Manifold Gangs Named without a submission number |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2011 | Not classified | Z-0469-2012 | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| Dec 6, 2011 | Not classified | Z-0470-2012 | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| Dec 6, 2011 | Not classified | Z-0479-2012 | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| Dec 6, 2011 | Not classified | Z-0480-2012 | Employee error | During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking collar to secure a connection. |
| May 17, 2011 | Not classified | Z-2623-2011 | Package design/selection | There is the potential for pinholes and tears in the individual packaging of the stopcocks, compromising the sterility of the product. |
| Oct 28, 2010 | Not classified | Z-0587-2011 | Device Design | Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy. |
| Oct 28, 2010 | Not classified | Z-0586-2011 | Device Design | Rotating the handle on the 3-Way Large Bore Stopcock past the stop can cause the stopcock to leak. A leak can lead to under-infusion or interruption of critical life-sustaining therapy. |
| Sep 9, 2010 | Not classified | Z-0151-2011 | Package design/selection | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
| Dec 15, 2005 | Not classified | Z-0654-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0655-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0656-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0646-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0653-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Feb 28, 2005 | Not classified | Z-0845-05 | Other | Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130245 (Baxter Healthcare Corp, 2013) has gone furthest, with 1 descendant of its own.
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?
These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962581: Stopcock Manifold Gangs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962581
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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