510(k) · Decided
DecidedOnecath L-Cath Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luther Medical Products, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Apr 7, 1994 after a 434-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 7, 1994
- Review
- 434 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK930473 Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
- Descendant · cites it directly · 5 of its ownK980090 Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
- Descendant · 2 generations on · 4 of its ownK992424 Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length)…Plastimed Laboratoire Pharmaceutique · 2000
- Descendant · 3 generations on · 3 of its ownK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- Descendant · 4 generations on · 2 of its ownK080793 FirmgripFlexicath, Ltd. · 2008
- Descendant · 5 generations on · 1 of its ownK092629 SNM FirmgripFlexicath, Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980090Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998 · cites it directly5descendants
- K992424Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 &…Plastimed Laboratoire Pharmaceutique · 2000 · 2 generations on4descendants
- K063363Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007 · 3 generations on3descendants
- K080793FirmgripFlexicath, Ltd. · 2008 · 4 generations on2descendants
- K092629SNM FirmgripFlexicath, Ltd. · 2009 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930473 | Onecath L-Cath Catheter System | Luther Medical Products, Inc. | 1994 | — |
| +1 | K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM) | Luther Medical Products, Inc. | 1998 | — |
| +2 | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models… | Plastimed Laboratoire Pharmaceutique | 2000 | — |
| +3 | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| +4 | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
| +5 | K092629 | SNM Firmgrip | Flexicath, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM) | 1998 | 5 |
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, K980090 (Luther Medical Products, Inc., 1998) has gone furthest, with 5 descendants of its own.
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) | — |
https://510kreport.com/device/K930473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930473: Onecath L-Cath Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930473
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026