510(k) · Cleared
ClearedNeo Mapcath Sensor Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corpak Medsystems · OMF Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Cleared on Feb 11, 2009 after a 112-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Feb 11, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- OMF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK083121 Neo Mapcath Sensor StyletCorpak Medsystems · 2009
- Descendant · cites it directly · 0 of its ownK093510 Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083121 | Neo Mapcath Sensor Stylet | Corpak Medsystems | 2009 | — |
| +1 | K093510 | Lumenvu Catheter Guidance System | Sonosite,Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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 OMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K093510 | Lumenvu Catheter Guidance System | 2010 | 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?
- Of its descendants, K093510 (Sonosite,Inc., 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OMF devicesOMF Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMF
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OMF
Too few OMF 510(k)s in any year since 2007 to give a median.
Recalls per year · OMF
No recall names OMF since 2007.
Adverse event reports per year · OMF
1in 2017
MAUDE reports naming product code OMF, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083121: Neo Mapcath Sensor Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083121
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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