510(k) Report

510(k) · Cleared

Cleared

AKCESS0CATH Kit

K925819510(k) TraditionalCleared Aug 2, 1994623-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. · LFJ Catheter, Subclavian

Cleared on Aug 2, 1994 after a 623-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Aug 2, 1994
Review
623 days
Class
Class II
Product code
LFJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK925819 AKCESS0CATH KitAkcess Medical Products, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK011916 Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series…Horizon Medical Products, Inc. · 2001
  3. Descendant · 2 generations on · 0 of its ownK022905 Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45…Horizon Medical Products, Inc. · 2001 · cites it directly1descendant
  • K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925819AKCESS0CATH KitAkcess Medical Products, Inc.1994—
+1K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40…Horizon Medical Products, Inc.2001—
+2K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
FIG. 1 — Lineage of K925819, 1994–2002Source: 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 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
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45…Horizon Medical Products, Inc.20011

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, K011916 (Horizon Medical Products, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LFJ devices

LFJ 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

2026 (partial year): 1, 1 Class I
2007high 1 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LFJ

28in 2025

2007: 272008: 222009: 262010: 452011: 232012: 342013: 292014: 232015: 262016: 342017: 312018: 312019: 452020: 432021: 372022: 342023: 442024: 482025: 28
2007high 48 (2024) · low 22 (2008)2025

MAUDE reports naming product code LFJ, 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—027
20080—022
20090—026
20100—045
20110—023
20120—034
20130—029
20140—023
20150—026
20160—034
20170—031
20180—031
20190—045
20200—043
20210—037
20220—034
20230—044
20240—048
20250—028
20260—1 (1)—

More from Akcess Medical Products, Inc.

36 FDA decisions under this applicant name. See the company

  • K926374Silicone Catheter Repair KitsAkcess Medical Products, Inc. · 1994
  • K925818Akcess-CathAkcess Medical Products, Inc. · 1994
  • K930630Right Atrial CatheterAkcess Medical Products, Inc. · 1994
  • K920634Splittable Sheath Introducer SetAkcess Medical Products, Inc. · 1994
  • K931120Coaxial Acute CatheterAkcess Medical Products, Inc. · 1994

Recent decisions in LFJ

The LFJ category page

  • K920780Medsurg Insertion TrayMedsurg Industries, Inc. · 1994
  • K925818Akcess-CathAkcess Medical Products, Inc. · 1994
  • K913468Uldall Double Lumen Hemodialysis Catheter Set/TrayCook, Inc. · 1994
  • K920634Splittable Sheath Introducer SetAkcess Medical Products, Inc. · 1994
  • K931120Coaxial Acute CatheterAkcess Medical Products, Inc. · 1994

https://510kreport.com/device/K925819 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925819: AKCESS0CATH Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925819

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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