# K021044: Madett

- Pathway: 510(k) (Traditional)
- Applicant: Wolfe Tory Medical, Inc.
- Decided: Sep 11, 2002 after 163 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802505 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802505: Double Lumen Tracheal Tube, National Catheter Co. Div. Mallinckrodt (1981)
- K971759: Medport Emergency Medication Airway Tube Adapter, Green Field Medical Sourcing, Inc. (1998) Summary page 1.
- (no number) Stat-Med: named in the summary without a submission number

## Recalls of this device
- Oct 27, 2016 · Class II · Z-0385-2017: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- Jun 6, 2003 · Not classified · Z-0965-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0962-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0963-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0964-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0966-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0967-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.
- Jun 6, 2003 · Not classified · Z-0968-03: Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

## Indications for use
1. To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway. 2. To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.

Source page: https://510kreport.com/device/K021044
Methodology: https://510kreport.com/methodology