510(k) · Cleared
ClearedVygon Double Lumen Umbilical Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiff & Co. · FOS Catheter, Umbilical Artery
Cleared on Oct 1, 1998 after a 147-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 1, 1998
- Review
- 147 days
- Class
- Class II
- Product code
- FOS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FOS? 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 FOS device
- #1 K201697 Umbilical Vessels Catheterscore 1.6 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FOS devicesFOS Catheter, Umbilical Artery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOS
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FOS
Too few FOS 510(k)s in any year since 2007 to give a median.
Recalls per year · FOS
No recall names FOS since 2007.
Adverse event reports per year · FOS
56in 2025
MAUDE reports naming product code FOS, 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 | 0 | — | 0 | 26 |
| 2008 | 2 | — | 0 | 42 |
| 2009 | 2 | — | 0 | 40 |
| 2010 | 0 | — | 0 | 94 |
| 2011 | 0 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 1 | — | 0 | 95 |
| 2014 | 0 | — | 0 | 69 |
| 2015 | 0 | — | 0 | 81 |
| 2016 | 0 | — | 0 | 115 |
| 2017 | 0 | — | 0 | 139 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 64 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 1 | — | 0 | 49 |
| 2022 | 0 | — | 0 | 38 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 52 |
| 2025 | 0 | — | 0 | 56 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Venous/arterial umbilical access in infants for infusion through one lumen and monitoring/blood sampling through the second lumen. May also be used for the infusion of incompatabfe solutions, through separate lumens.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981630: Vygon Double Lumen Umbilical Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981630
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026