510(k) Report

510(k) · Decided

Decided

Continuous Arteriovenous Hemofiltration Cath Set

K914936510(k) TraditionalDecided Apr 23, 1992171-day reviewClass II21 CFR 876.5540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Akcess Medical Products, Inc. · LFK Catheter, Femoral

Cleared on Apr 23, 1992 after a 171-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Apr 23, 1992
Review
171 days
Class
Class II
Product code
LFK
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK914936 Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK971897 Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971897Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914936Continuous Arteriovenous Hemofiltration Cath SetAkcess Medical Products, Inc.1992—
+1K971897Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K914936, 1992–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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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.

NumberDeviceApplicantDecidedDescendants
K971897Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc.19970

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?

  • Of its descendants, K971897 (Medron, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LFK devices

LFK 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

2008: 6
2007high 6 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFK

2in 2023

2007: 12008: 12012: 12013: 12020: 12021: 22023: 2
2007high 2 (2021) · low 0 (2009)2025

MAUDE reports naming product code LFK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—61
20090—00
20100—00
20110—00
20120—01
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—02
20220—00
20230—02
20240—00
20250—00
20260—0—

More from Akcess Medical Products, Inc.

36 FDA decisions under this applicant name. See the company

  • K926374Silicone Catheter Repair KitsAkcess Medical Products, Inc. · 1994
  • K925819AKCESS0CATH KitAkcess Medical Products, Inc. · 1994
  • K925818Akcess-CathAkcess Medical Products, Inc. · 1994
  • K930630Right Atrial CatheterAkcess Medical Products, Inc. · 1994
  • K931120Coaxial Acute CatheterAkcess Medical Products, Inc. · 1994

Recent decisions in LFK

The LFK category page

  • K971897Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)Medron, Inc. · 1997
  • K915215Continuous Arteriovenous Hemofiltration Cath. KitsAkcess Medical Products, Inc. · 1992
  • K891763FC-100 Femoral CatheterAkcess Medical Products, Inc. · 1989
  • K891764FC-101 Femoral Catheter Guide WireAkcess Medical Products, Inc. · 1989
  • K890717Modification Hemofiltration Catheter HF-100Vas-Cath, Inc. · 1989

https://510kreport.com/device/K914936 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914936: Continuous Arteriovenous Hemofiltration Cath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914936

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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