510(k) · Cleared
Recalled · 2004Stopcocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transamerica Delaval, Inc. · FMG Stopcock, I.V. Set
Cleared on May 23, 1985 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 10 times.
- Decided
- May 23, 1985
- Review
- 16 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 10
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Sep 9, 2004 | Not classified | Z-0235-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0237-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0239-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0234-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0242-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0236-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0238-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0240-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0241-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0243-05 | Other | Sterility of the device is compromised due to packaging defects |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K851986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K851986: Stopcocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851986
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026