510(k) · Cleared
ClearedNeomed Single Lumen Umbilical Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomed, Inc. · FOS Catheter, Umbilical Artery
Cleared on Feb 22, 2008 as substantially equivalent to K944368 (Catco Medical, Inc., 1995) after a 63-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Feb 22, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- FOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944368 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK944368 Catco Silicone Umbilical Vessel CatheterCatco Medical, Inc. · 1995
- This deviceK073596 Neomed Single Lumen Umbilical CatheterNeomed, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK081515 Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0Neomed, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081515Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0Neomed, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944368 | Catco Silicone Umbilical Vessel Catheter | Catco Medical, Inc. | 1995 | — |
| 0 (this device) | K073596 | Neomed Single Lumen Umbilical Catheter | Neomed, Inc. | 2008 | — |
| +1 | K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0 | Neomed, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K944368 | Catco Silicone Umbilical Vessel CatheterSummary page 1…ss IIper 21 CFR §880.5200 CLASSIFICATION AND PRODUCT Product Code: 80 FOS CODE PREDICATE CATCO Umbilical Vessel Catheter (K944368) DEVICE NAME SUBSTANTIAL EQUIVALENCE: The NeoMed Single Lumen Umbilical Catheter is substantially equivalent to the C… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081515 | Neomed Dual Lumen Umbilical Catheter, Models S2UVC4.0, S2UVC5.0 | 2008 | 0 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K081515 (Neomed, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FOS devicesFOS Catheter, Umbilical Artery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The NeoMed Single Lumen Umbilical Catheter is intended for use in neonatal and pediatric patients to patients to sample blood, monitor blood pressure, or administer fluids intravenously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073596 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073596: Neomed Single 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/K073596
Report an extraction error
Are you the manufacturer?
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