# K932184: Sterile Lemaitre Glow 'N Tell Tape

- Pathway: 510(k) (Traditional)
- Applicant: Vascutech, Inc.
- Decided: Jul 22, 1993 after 78 days
- Product code: KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External)
- Device class: 2
- Regulation: 21 CFR 890.3500
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Mar 18, 2013 · Class II · Z-1054-2013: 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: 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: Box label (Top Part). Lot and Expiration Date information were switched.
- Oct 22, 2010 · Not classified · Z-0435-2011: Box label (Top Part). Lot and Expiration Date information were switched.
- Oct 22, 2010 · Not classified · Z-0436-2011: Box label (Top Part). Lot and Expiration Date information were switched.
- Oct 22, 2010 · Not classified · Z-0433-2011: Box label (Top Part). Lot and Expiration Date information were switched.

Source page: https://510kreport.com/device/K932184
Methodology: https://510kreport.com/methodology