510(k) · Cleared
Recalled · 2007Vaccess 2000 Single Lumen Subclavian Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vas-Cath of Canada, Ltd. · LFJ Catheter, Subclavian
Cleared on Mar 13, 1985 after a 117-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Mar 13, 1985
- Review
- 117 days
- Class
- Class II
- Product code
- LFJ
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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 LFJ? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2007 | Not classified | Z-1229-2007 | Other | Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end. |
No ancestor or descendant has a Class I recall.
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/K844433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844433: Vaccess 2000 Single Lumen Subclavian Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844433
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026