# K021540: Rusch Edgar Tube

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Aug 1, 2002 after 83 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: 2 generations back to K961837 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 8 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.
- K861454: End Tidal CO2 Tube, Sheridan Catheter Corp. (1986) Summary page 1.
- K834463: Laryngotracheal Topical Anes. Appli, Sheridan Catheter Corp. (1984) Summary page 1.
- (no number) Rusch Safety Tracheal Tubes - Preamendment: named in the summary without a submission number
- (no number) The Mallinckrodt Emergency Medical Tube (EMT): named in the summary without a submission number

## Most influential descendants
- K023964: Rusch Microlaryngeal Tube (2002), 0 descendants of its own

## Indications for use
The Rusch Edgar Tube is a sterile, single-use, oral/nasal tracheal tube intended to be used for airway management. The integral instillation system is indicated for drug instillation by the endobronchial route, anesthetic administration and gas monitoring.

Source page: https://510kreport.com/device/K021540
Methodology: https://510kreport.com/methodology