# K023964: Rusch Microlaryngeal Tube

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Dec 23, 2002 after 24 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961837 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
4 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye, Rusch, Inc. (1993) Summary page 1.
- K931166: Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/Mur EY, Rusch, Inc. (1993) Summary page 1.
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy, Rusch Intl. (2000) Summary page 1.
- K021540: Rusch Edgar Tube, Rusch Intl. (2002)
- K860176: Laryngectomy Tube, Cuffed, Sheridan Catheter Corp. (1986) Summary page 1.
- K801005: MLT Tube Microlaryngeal Tracheal Tube), National Catheter Co. Div. Mallinckrodt (1980) Summary page 1.
- (no number) Rusch Safety Tracheal Tubes - Preamendment: named in the summary without a submission number

## Indications for use
The Rusch Microlaryngeal Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management during laryngeal procedures.

Source page: https://510kreport.com/device/K023964
Methodology: https://510kreport.com/methodology