510(k) · Cleared

Recalled · Class II · 2013

Sterile Lemaitre Glow 'N Tell Tape

K932184510(k) TraditionalCleared Jul 22, 199378-day reviewClass II21 CFR 890.3500Recalls 6

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

Vascutech, Inc. · KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External

Cleared on Jul 22, 1993 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 6 times.

Decided: Jul 22, 1993
Review: 78 days
Class: Class II
Product code: KFX
Recalls: 6
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 K932184Source: FDA 510(k) database · How lineage is built

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.

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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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 18, 2013	Class II	Z-1054-2013	Packaging process control	Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Mar 18, 2013	Class II	Z-1055-2013	Packaging process control	Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Oct 22, 2010	Not classified	Z-0434-2011	Labeling Change Control	Box label (Top Part). Lot and Expiration Date information were switched.
Oct 22, 2010	Not classified	Z-0435-2011	Labeling Change Control	Box label (Top Part). Lot and Expiration Date information were switched.
Oct 22, 2010	Not classified	Z-0436-2011	Labeling Change Control	Box label (Top Part). Lot and Expiration Date information were switched.
Oct 22, 2010	Not classified	Z-0433-2011	Labeling Change Control	Box label (Top Part). Lot and Expiration Date information were switched.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KFX devices

KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KFX

FDA has decided no KFX device since 2007.

Median 510(k) review, days · KFX

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

Recalls per year · KFX

2in 2013

2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · KFX

1in 2024

2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code KFX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	2	2
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	1
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/K932184 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932184: Sterile Lemaitre Glow 'N Tell Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932184

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Record history

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