510(k) · Cleared
Recalled · Class II · 2026Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMG Stopcock, I.V. Set
Cleared on Jan 13, 1998 after a 76-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 13 times.
- Decided
- Jan 13, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 13
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK974083 Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way StopcocksOhmeda Medical · 1998
- Descendant · cites it directly · 0 of its ownK070143 JMS Planecta StopcockJms North America Corp. · 2007
- Descendant · cites it directly · 0 of its ownK012157 Churchill Medical Systems StopcockChurchill Medical Systems, Inc. · 2001 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K974083 | Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks | Ohmeda Medical | 1998 | — |
| +1 | K070143 | JMS Planecta Stopcock | Jms North America Corp. | 2007 | — |
| +1 | K012157 | Churchill Medical Systems Stopcock | Churchill Medical Systems, Inc. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | — | Connecta® TH (through hole) 2-way and 3-way Infusion/Pressure Monitoring Stopcocks Named without a submission number |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2514-2026 | Device Design | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as… |
| Feb 20, 2025 | Class II | Z-1509-2025 | Labeling Change Control | Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) |
| May 9, 2022 | Class II | Z-1439-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1434-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1436-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1433-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1441-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1432-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1437-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1435-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1431-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1440-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
| May 9, 2022 | Class II | Z-1438-2022 | Under Investigation by firm | May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070143 (Jms North America Corp., 2007) has gone furthest, with 0 descendants 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?
Connecta® Plus 1 and Connecta® Plus 3 2-way and 3-way Stopcocks are control valves for use in I.V. therapy and hemodynamic pressure monitoring. They are added to IV cannula or extension tubing sets for simultaneous or alternate administration of IV drugs, fluids, and blood, or for blood sampling. They can also be used in areas in which solution flow requires control. Alternatively, they are used for hemodynamic monitoring via an arterial cannula and a central venous catheter.
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/K974083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974083: Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974083
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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