510(k) · Cleared
ClearedFootprint Medical Polyurethane Umbilical Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Footprint Medical, Inc. · FOS Catheter, Umbilical Artery
Cleared on Mar 1, 2012 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 1, 2012
- Review
- 29 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. 2012, this device’s year, is highlighted.
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?
This product is intended for use in neonatal patients to sample blood, monitor blood pressure,
or administer fluids intravenously.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120304 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120304: Footprint Medical Polyurethane 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/K120304
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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