510(k) · Cleared
Recalled · Class II · 2023Stopcock & Luer Lock Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medex, Inc. · FMG Stopcock, I.V. Set
Cleared on Apr 22, 1996 as substantially equivalent to K861563 (Vitaphore Corp., 1986) after a 175-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 22, 1996
- Review
- 175 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861563 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK861563 Vitaguard Percutaneous Infection Control KitVitaphore Corp. · 1986
- This deviceK954970 Stopcock & Luer Lock PlugMedex, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK053405 BacstopElcam Medical Acal · 2006
- Descendant · 2 generations on · 0 of its ownK082106 Elcam Antimicrobial Closed Stopcocks (DSS and TSS)Elcam Medical Acal · 2008
- Descendant · 2 generations on · 0 of its ownK073396 Antimicrobial Ultrasite Value, Ultrasite AGB.Braun Medical, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861563 | Vitaguard Percutaneous Infection Control Kit | Vitaphore Corp. | 1986 | — |
| 0 (this device) | K954970 | Stopcock & Luer Lock Plug | Medex, Inc. | 1996 | — |
| +1 | K053405 | Bacstop | Elcam Medical Acal | 2006 | — |
| +2 | K082106 | Elcam Antimicrobial Closed Stopcocks (DSS and TSS) | Elcam Medical Acal | 2008 | — |
| +2 | K073396 | Antimicrobial Ultrasite Value, Ultrasite AG | B.Braun Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K861563 | Vitaguard Percutaneous Infection Control KitSummary page 1…spectively. « Additionally, the modified devices use a substantially equivalent technology as the Vitaphore Corporation’s VitaGuard® Percutaneous Infection Control Kit (K861563). § 807.92 (a)(4) Description of the Premarket Notification Device » The Medex, Inc. antimicrobial stopcock and Luer lock plug… | 1986 |
| * | — | Medex, Inc.’s pre-amendment stopcock MX531-1L Named without a submission number | |
| * | — | Medex, Inc.’s pre-amendment Luer lock plug MX491 Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053405 | Bacstop | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2023 | Class II | Z-0745-2024 | Nonconforming Material/Component | There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of… |
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.
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?
A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port. The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.
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/K954970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954970: Stopcock & Luer Lock Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954970
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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