510(k) · Cleared
ClearedContinuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medron, Inc. · LFK Catheter, Femoral
Cleared on Oct 21, 1997 as substantially equivalent to K914936 (Akcess Medical Products, Inc., 1992) after a 152-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 21, 1997
- Review
- 152 days
- Class
- Class II
- Product code
- LFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914936 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK914936 Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc. · 1992
- This deviceK971897 Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914936 | Continuous Arteriovenous Hemofiltration Cath Set | Akcess Medical Products, Inc. | 1992 | — |
| 0 (this device) | K971897 | Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh) | Medron, Inc. | 1997 | — |
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 LFK? 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? (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 |
|---|---|---|---|
| * | K914936 | Continuous Arteriovenous Hemofiltration Cath SetSummary page 1…EDRON CAVH Continuous Arteriovenous Hemofiltration Catheter Class 11 Continuous Arteriovenous Hemofiltration Catheter NEOSTAR CAVH #1045 AKCESS Medical Products, Inc. K914936 Vascular access for continuous hemofiltration. Alleviates hypervolemic states in patients with impaired or absent renal functio… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All LFK devicesLFK Catheter, Femoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFK
FDA has decided no LFK device since 2007.
Median 510(k) review, days · LFK
Too few LFK 510(k)s in any year since 2007 to give a median.
Recalls per year · LFK
6in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFK
2in 2023
MAUDE reports naming product code LFK, 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 | 1 |
| 2008 | 0 | — | 6 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indication for use of the MEDRON CAVH Catheter is for accessing the vascular system for continuous arteriovenous hemofiltration.
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/K971897 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971897: Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971897
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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