510(k) · Cleared
Cleared1.4 FR Mapcath Sensor Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navion Biomedical Corp. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 12, 1997 as substantially equivalent to K935380 (Bard Access Systems, Inc., 1995) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Nov 12, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901263 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK901263 Navion Smart-Wire (TM) Catheter Location SystemNavion Biomedical Corp. · 1990
- This deviceK973057 1.4 FR Mapcath Sensor StyletNavion Biomedical Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901263 | Navion Smart-Wire (TM) Catheter Location System | Navion Biomedical Corp. | 1990 | — |
| 0 (this device) | K973057 | 1.4 FR Mapcath Sensor Stylet | Navion Biomedical Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K935380 | Vascular Access Catheter AccessoriesSummary page 1…nsor stylet described in this pre-market notification are substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263. A tabl… | 1995 |
| * | K901263 | Navion Smart-Wire (TM) Catheter Location SystemSummary page 1…ylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263. A table comparing the physical features of the proposed 1.4 Fr MAPCath sensor stylet to the one that received concurrence under… | 1990 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K935380.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the NAVIGATOR catheter locator instrument to aid in the placement of central venous catheters (CVCs) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973057: 1.4 FR 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/K973057
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