510(k) · Cleared
ClearedVas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vas-Cath, Inc. · LFJ Catheter, Subclavian
Cleared on Jul 1, 1993 after a 653-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 1, 1993
- Review
- 653 days
- Class
- Class II
- Product code
- LFJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK914162 Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersVas-Cath, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK030268 Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual…C.R. Bard, Inc. · 2003 · Recalled (Class I)
Class I recalls in this family
- K030268 Niagara Temporary Dual Lumen Catheters…cites it directly · 2003
Most influential descendants
Showing 1 of 1 · See all- K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters | Vas-Cath, Inc. | 1993 | — |
| +1 | K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen… | C.R. Bard, Inc. | 2003 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters Class I | 2003 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K030268Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersC.R. Bard, Inc. · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030268 (C.R. Bard, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFJ devicesLFJ Catheter, Subclavian: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFJ
FDA has decided no LFJ device since 2007.
Median 510(k) review, days · LFJ
Too few LFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFJ
1so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LFJ
28in 2025
MAUDE reports naming product code LFJ, 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 | 27 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 45 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 0 | — | 0 | 31 |
| 2018 | 0 | — | 0 | 31 |
| 2019 | 0 | — | 0 | 45 |
| 2020 | 0 | — | 0 | 43 |
| 2021 | 0 | — | 0 | 37 |
| 2022 | 0 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 44 |
| 2024 | 0 | — | 0 | 48 |
| 2025 | 0 | — | 0 | 28 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K914162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914162: Vas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914162
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026