510(k) Report

510(k) · Cleared

Cleared

Immobile Non-Sterile and Immobile a/C Non-Sterile

K941850510(k) TraditionalCleared Jul 14, 199491-day reviewClass I21 CFR 880.5210

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

Tnt Moborg Intl., Ltd. · KMK Device, Intravascular Catheter Securement

Cleared on Jul 14, 1994 after a 91-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
Jul 14, 1994
Review
91 days
Class
Class I
Product code
KMK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK941850 Immobile Non-Sterile and Immobile a/C Non-SterileTnt Moborg Intl., Ltd. · 1994
  2. Descendant · cites it directly · 0 of its ownK062953 Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K062953Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941850Immobile Non-Sterile and Immobile a/C Non-SterileTnt Moborg Intl., Ltd.1994—
+1K062953Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K941850, 1994–2007Source: FDA 510(k) summaries, read by 510(k) Report · 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 KMK? 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
K062953Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceMedisystems Corp.20070

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, K062953 (Medisystems Corp., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KMK devices

KMK Device, Intravascular Catheter Securement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMK

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMK

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

Recalls per year · KMK

2in 2016

2007: 32016: 2
2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KMK

75in 2025

2007: 12008: 72009: 32010: 52011: 22012: 12013: 42014: 182015: 412016: 192017: 452018: 402019: 102020: 142021: 332022: 1032023: 1382024: 1042025: 75
2007high 138 (2023) · low 1 (2007)2025

MAUDE reports naming product code KMK, 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—31
20080—07
20090—03
20100—05
20110—02
20120—01
20130—04
20140—018
20150—041
20160—219
20170—045
20180—040
20191—010
20200—014
20210—033
20220—0103
20230—0138
20240—0104
20250—075
20260—0—

More from Tnt Moborg Intl., Ltd.

3 FDA decisions under this applicant name. See the company

  • K941940Immobile Sterile and Immobile a/C SterileTnt Moborg Intl., Ltd. · 1994
  • K915565ImmobileTnt Moborg Intl., Ltd. · 1992

Recent decisions in KMK

The KMK category page

  • K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc. · 2019
  • K981860A P HarnessParaworks Enterprise, Ltd. · 1999
  • K963365Multi-Purpose Medical Tube HolderByrd Medical Devices, Inc. · 1996
  • K941098Secure-SiteOp-Co Medical Products, Ltd. · 1995
  • K943147Statlock CVVenetec, Inc. · 1994

https://510kreport.com/device/K941850 · printed Nov 4, 2026

Cite this page

510(k) Report. “K941850: Immobile Non-Sterile and Immobile a/C Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K941850

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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