510(k) · Cleared
ClearedOnecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)
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 Mar 24, 1998 as substantially equivalent to K930473 (Luther Medical Products, Inc., 1994) after a 74-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Mar 24, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930473 (1994). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930473 Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
- This deviceK980090 Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
- Descendant · cites it directly · 4 of its ownK992424 Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length)…Plastimed Laboratoire Pharmaceutique · 2000
- Descendant · 2 generations on · 3 of its ownK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- Descendant · 3 generations on · 2 of its ownK080793 FirmgripFlexicath, Ltd. · 2008
- Descendant · 4 generations on · 1 of its ownK092629 SNM FirmgripFlexicath, Ltd. · 2009
- Descendant · 4 generations on · 0 of its ownK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K992424Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 &…Plastimed Laboratoire Pharmaceutique · 2000 · cites it directly4descendants
- K063363Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007 · 2 generations on3descendants
- K080793FirmgripFlexicath, Ltd. · 2008 · 3 generations on2descendants
- K092629SNM FirmgripFlexicath, Ltd. · 2009 · 4 generations on1descendant
- K111939M/29TM - Pressure InjectableFlexicath, Ltd. · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930473 | Onecath L-Cath Catheter System | Luther Medical Products, Inc. | 1994 | — |
| 0 (this device) | K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM) | Luther Medical Products, Inc. | 1998 | — |
| +1 | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models… | Plastimed Laboratoire Pharmaceutique | 2000 | — |
| +2 | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| +3 | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
| +4 | K092629 | SNM Firmgrip | Flexicath, Ltd. | 2009 | — |
| +4 | K111939 | M/29TM - Pressure Injectable | Flexicath, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K930473 | Onecath L-Cath Catheter System Our OCR of the scanned summary read K930743, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “ONECATH”. | 1994 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 &… | 2000 | 4 |
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, K992424 (Plastimed Laboratoire Pharmaceutique, 2000) has gone furthest, with 4 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) | — |
What is it indicated for?
The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein. Note: This product may be used in pediatric as well as adult patients. Vascular…
Read the full statement (126 words)
The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein.
Note: This product may be used in pediatric as well as adult patients. Vascular cannulation is an important Procedure in the management of ill infants and children. The indications for use in children are the same as adults; however, insertion techniques are often modified according to the age and size of a child. If the practitioner is inexperienced in utilizing this product in a child, appropriate consultation should be sought.
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/K980090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980090: Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980090
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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