510(k) · Cleared
Recalled · Class II · 2017Churchill Medical Systems Stopcock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Churchill Medical Systems, Inc. · FMG Stopcock, I.V. Set
Cleared on Sep 11, 2001 as substantially equivalent to K974083 (Ohmeda Medical, 1998) after a 62-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Sep 11, 2001
- Review
- 62 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974083 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK974083 Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way StopcocksOhmeda Medical · 1998 · Recalled
- This deviceK012157 Churchill Medical Systems StopcockChurchill Medical Systems, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974083 | Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks | Ohmeda Medical | 1998 | 13 |
| 0 (this device) | K012157 | Churchill Medical Systems Stopcock | Churchill Medical Systems, Inc. | 2001 | — |
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 |
|---|---|---|---|
| * | K974083 | Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way StopcocksSummary page 1…Stopcock Latex Free, Lipid Resistant IV Set Stopcock, IV Administration Set Class II, General Hospital 80 FPA Ohmeda Connecta Plus 1 and Plus 3, 2 and 3 way stopcocks (K974083) The Churchill Medical Systems 4 way stopcock consist of a housing with two one male luer with rotating lock ring. The diversion… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-0682-2018 | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K974083.
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?
Churchill Medical Systems Stopcock is a valve for use in I.V. therapy and pressure monitoring to direct and control the flow of medical fluids.
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/K012157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012157: Churchill Medical Systems Stopcock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012157
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026