# K042683: Well Lead Endotracheal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Instruments
- Decided: Feb 18, 2005 after 142 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961837 (1996). 4 ancestors in all.
23 later devices descend from it; 10 cite it directly.
5 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy, Rusch Intl. (1996) Summary page 1.
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy, Rusch Intl. (2000) Summary page 1.
- K961840: Rusch Oral/Nasal Tracheal Tube, Plain Magill/Murphy, Rusch Intl. (1996) Summary page 1.
- K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye, Rusch, Inc. (1993) Summary page 1.
- (no number) Kendall - Pre-Amendment: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K093786: Ruschelit. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K111401: Bever Endotracheal Tube, Bever Eva Endotracheal Tube (2012), 5 descendants of its own
- K073383: Well Lead Reinforced Endotracheal Tube (2008), 5 descendants of its own
- K151381: Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (2015), 3 descendants of its own
- K093126: Anapnoguard Endotracheal Tube (2010), 3 descendants of its own
- K223130: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) (2023), 2 descendants of its own

## Recalls of this device
- Jul 31, 2026 · Class II · Z-3172-2026: The 6Fr suction catheter could not pass through the samples smoothly.

## Indications for use
The device is intended for oral or nasal intubation and for airway management.

Source page: https://510kreport.com/device/K042683
Methodology: https://510kreport.com/methodology