510(k) Report

510(k) · Cleared

Cleared

Dual Lumen Needles

K904433510(k) TraditionalCleared Nov 23, 199056-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. · LBW Set, Dialysis, Single Needle (Co-Axial Flow)

Cleared on Nov 23, 1990 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1990
Review
56 days
Class
Class II
Product code
LBW
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K904433Source: FDA 510(k) database · How lineage is built

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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 LBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LBW devices

LBW Set, Dialysis, Single Needle (Co-Axial Flow): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBW

FDA has decided no LBW device since 2007.

Median 510(k) review, days · LBW

Too few LBW 510(k)s in any year since 2007 to give a median.

Recalls per year · LBW

No recall names LBW since 2007.

Adverse event reports per year · LBW

No MAUDE report names LBW since 2007.

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

The LBW category page

  • K864629Modified Dual Lumen NeedleQuinton, Inc. · 1986
  • K860515Dual Lumen Needle (Product Change)Quinton, Inc. · 1986
  • K820859Coaxial Dual Flow CatheterTerumo Medical Corp. · 1982
  • K801968Hemocath I Kidney Dialysis CatheterMedical Components, Inc. · 1980

https://510kreport.com/device/K904433 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904433: Dual Lumen Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904433

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026