510(k) Report

510(k) · Cleared

Cleared

DC-4 Shunt Infusion T

K891754510(k) TraditionalCleared Apr 7, 198915-day reviewClass II21 CFR 876.5820

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. · FKB Connector, Blood Tubing, Infusion T

Cleared on Apr 7, 1989 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 7, 1989
Review
15 days
Class
Class II
Product code
FKB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K891754Source: 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 FKB? 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 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 FKB devices

FKB Connector, Blood Tubing, Infusion T: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKB

FDA has decided no FKB device since 2007.

Median 510(k) review, days · FKB

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

Recalls per year · FKB

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · FKB

1in 2021

2017: 12018: 12019: 22021: 1
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code FKB, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—10
20140—00
20150—00
20160—00
20170—01
20180—01
20190—02
20200—00
20210—01
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 FKB

The FKB category page

  • K771426Pediatric Infusion TQuinton, Inc. · 1977

https://510kreport.com/device/K891754 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891754: DC-4 Shunt Infusion T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891754

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