510(k) · Cleared
Recalled · Class II · 2025Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo
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 Mar 1, 2013 as substantially equivalent to K962581 (Baxter Healthcare Corp, 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 1, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961225 (1996). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK961225 Continuflo Solution Set/Secondary Medication SetBaxter Healthcare Corp · 1996 · Recalled
- This deviceK130245 Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock…Baxter Healthcare Corp · 2013
- Descendant · cites it directly · 0 of its ownK223175 lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961225 | Continuflo Solution Set/Secondary Medication Set | Baxter Healthcare Corp | 1996 | 7 |
| 0 (this device) | K130245 | Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with… | Baxter Healthcare Corp | 2013 | — |
| +1 | K223175 | lntravascular Administration Sets with Stopcock and Manifold | Baxter Healthcare Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K962581 | Stopcock Manifold GangsSummary page 2…date 510(k) ________ Stopcock Manifold Gangs Baxter Healthcare Corp. K962581 August 28, 1996 Continu-Flo Solution Baxter Healthcare Corp. K961225 June 21, 1996 Set/Secon… | 1996 |
| * | K961225 | Continuflo Solution Set/Secondary Medication SetSummary page 2…Stopcock Manifold Gangs Baxter Healthcare Corp. K962581 August 28, 1996 Continu-Flo Solution Baxter Healthcare Corp. K961225 June 21, 1996 Set/Secondary Medication Set Device Description: The proposed devices, which are the subject of this Spe… | 1996 |
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 |
|---|---|---|---|
| K223175 | lntravascular Administration Sets with Stopcock and Manifold | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2025 | Class II | Z-0189-2026 | Process control | IV sets may leak. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
To administer fluids from a container into the patient's vascular system through a vascular access device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130245: Large Bore Stopcock with Rotating Male Luer Lock/Large Bore Stopcock with Extension Set, Gang Large Bore Stopcock Manifo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130245
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