510(k) Report

510(k) · Cleared

Cleared

Splittable Sheath Introducer Set

K920634510(k) TraditionalCleared Jan 14, 1994702-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 Jan 14, 1994 after a 702-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 14, 1994
Review
702 days
Class
Class II
Product code
LFJ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K920634Source: 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 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?

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 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
  • 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 LFJ

The LFJ category page

  • K920780Medsurg Insertion TrayMedsurg Industries, Inc. · 1994
  • K925819AKCESS0CATH KitAkcess Medical Products, Inc. · 1994
  • K925818Akcess-CathAkcess Medical Products, Inc. · 1994
  • K913468Uldall Double Lumen Hemodialysis Catheter Set/TrayCook, Inc. · 1994
  • K931120Coaxial Acute CatheterAkcess Medical Products, Inc. · 1994

https://510kreport.com/device/K920634 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920634: Splittable Sheath Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920634

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