510(k) · Cleared
ClearedSeldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastimed Laboratoire Pharmaceutique · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Dec 29, 2000 as substantially equivalent to K823553 (Cormed, Inc., Sub. C.R.Bard, Inc., 1983) and 1 other predicate after a 527-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 29, 2000
- Review
- 527 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930473 (1994). 3 ancestors in all, the oldest K823553 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930473 Onecath L-Cath Catheter SystemLuther Medical Products, Inc. · 1994
- 1 generation backK980090 Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Luther Medical Products, Inc. · 1998
- This deviceK992424 Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length)…Plastimed Laboratoire Pharmaceutique · 2000
- Descendant · cites it directly · 3 of its ownK063363 Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK080793 FirmgripFlexicath, Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK092629 SNM FirmgripFlexicath, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK111939 M/29TM - Pressure InjectableFlexicath, Ltd. · 2012
Most influential descendants
Showing 4 of 4 · See all- K063363Firmgrip Peripherally Inserted Catheter DeviceFlexicath, Ltd. · 2007 · cites it directly3descendants
- K080793FirmgripFlexicath, Ltd. · 2008 · 2 generations on2descendants
- K092629SNM FirmgripFlexicath, Ltd. · 2009 · 3 generations on1descendant
- K111939M/29TM - Pressure InjectableFlexicath, Ltd. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K992424 | Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models… | Plastimed Laboratoire Pharmaceutique | 2000 | — |
| +1 | K063363 | Firmgrip Peripherally Inserted Catheter Device | Flexicath, Ltd. | 2007 | — |
| +2 | K080793 | Firmgrip | Flexicath, Ltd. | 2008 | — |
| +3 | K092629 | SNM Firmgrip | Flexicath, Ltd. | 2009 | — |
| +3 | K111939 | M/29TM - Pressure Injectable | Flexicath, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K823553 | Corcath H & B Vascular Access CatheterSummary page 1…Unclassified LIS The Seldiflex® central venous catheter is substantially equivalent to the Hickman/Broviac central venous catheters manufactured by Bard Access Systems (K823553) and the ONECATH® long-term intravascular catheters manufactured by Luther Medical Products, Inc. (K980090), and other similar de… | 1983 |
| * | K980090 | Onecath, L-Cath Catheter System, Model OC-(16-22 GA., 5CM-60CM)Summary page 1…central venous catheters manufactured by Bard Access Systems (K823553) and the ONECATH® long-term intravascular catheters manufactured by Luther Medical Products, Inc. (K980090), and other similar devices made by other manufacturers. The Seldiflex® is a single lumen, radiopaque polyurethane, long-term ce… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063363 | Firmgrip Peripherally Inserted Catheter Device | 2007 | 3 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063363 (Flexicath, Ltd., 2007) has gone furthest, with 3 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?
Plastimed’s Seldiflex® central venous catheter is intended for long-term vascular access and is indicated for use with patients who require central venous pressure monitoring, L.V. fluids, blood products, drugs, or parenteral nutrition solutions.
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/K992424 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992424: Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992424
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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