Rusch Safety Clear Plus Cuffed W/Murphy Eye

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K925505 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Rusch Safety Clear Uncuffed with Magill Tip

  Class II

  FDA 510(k) K925507 Active Cleared 2 Sep 1993

• Rusch Agt Pvc Pref Oral Trach Tube, Uncuf W/Mur Ey Open recall

  Class II

  FDA 510(k) K931166 Active Cleared 22 Jun 1993

• Rusch Tracheal Bronchial Y Stent

  Class II

  FDA 510(k) K953593 Active Cleared 13 Oct 1995

• Rusch Agt Pvc Pref Nasal Trach Tub/Uncuf W/Mur Eye Open recall

  Class II

  FDA 510(k) K931165 Active Cleared 22 Jun 1993

• Rusch Lasertubus/Rusch Laser Resistant Cuffed with Murphy Eye

  Class II

  FDA 510(k) K935842 Active Cleared 23 May 1995

• Rusch Simplastic Foley Catheterization Set

  Class II

  FDA 510(k) K963993 Active Cleared 17 Dec 1996

See all devices from Rusch, Inc. →

• What is the primary purpose of the Murphy Eye feature in this tracheal tube, and how does it improve patient safety during procedures?

  The Murphy Eye design provides an alternative ventilation port in case the primary lumen becomes obstructed. This ensures continuous airflow to the patient, reducing the risk of hypoxia and improving safety during intubation or emergency procedures.

• Is this tracheal tube reusable, or is it intended for single-use only? What does that mean for clinical workflows?

  This device is explicitly designed for single-use only, meaning it must be discarded after one procedure to maintain sterility and hygiene standards. Clinicians should follow manufacturer guidelines to avoid reuse, as this could compromise patient safety and violate infection control protocols.

• What sizes or models are available for this cuffed tracheal tube, and how do I determine the correct size for a patient?

  While the exact size range isn’t specified in the provided data, the device is available in multiple sizes to accommodate different patient anatomies. Selection should be based on clinical assessment (e.g., age, sex, and tracheal diameter) and institutional protocols. Always verify compatibility with the patient’s airway before use.

• How should this tracheal tube be stored to ensure it remains sterile and intact before use?

  The device must be stored under sterile conditions as supplied to preserve its integrity. Check the packaging for expiration dates, and avoid exposure to moisture, extreme temperatures, or contamination. Once opened, it should be used immediately to prevent compromise of sterility.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?

  This tracheal tube received FDA 510(k) clearance (K925505), meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance under Class II standards (21 CFR 868.5730) ensures it meets safety and performance requirements for use in anesthesiology settings, though clinicians should always follow local protocols and institutional guidelines.