Kendall Safetrak Combined Epidural/Spinal Kit

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

510(k) Number

K941493 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SEKD

• Curity Vented Dressing System

  Unclassified

  FDA 510(k) K915635 Active Cleared 31 Jan 1992

• Kendall Universal Extension Set

  Class I

  FDA 510(k) K930551 Active Cleared 12 May 1993

• Kendall Home Rx Therapeutic Stocking

  Class II

  FDA 510(k) K925417 Active Cleared 4 Jun 1993

• Curad Kid Size Instant Cold Pack

  Class I

  FDA 510(k) K920252 Active Cleared 11 Feb 1992

• Curity(R) Calib Tuohy Type Epidur Needle Fix Wing

  Class II

  FDA 510(k) K910791 Active Cleared 17 May 1991

• Curity Pediatric Continuous Caudal Anesthesia Tray

  Class II

  FDA 510(k) K902647 Active Cleared 29 Nov 1990

See all devices from Kendall Healthcare Products Co. Div.Of Tyco Health →

• What is the Kendall Safetrak Combined Epidural/Spinal Kit used for?

  The Kendall Safetrak Combined Epidural/Spinal Kit is designed for combined epidural and spinal anesthesia procedures, providing the necessary components for anesthesia conduction in clinical settings as indicated in its FDA 510(k) clearance.

• How is the Kendall Safetrak Combined Epidural/Spinal Kit supplied and is it sterile?

  The kit is supplied as a pre-assembled, sterile package intended for single-use in clinical anesthesia procedures, ensuring readiness and infection control for combined epidural and spinal techniques.

• What regulatory clearance does the Kendall Safetrak Combined Epidural/Spinal Kit have?

  The device received FDA 510(k) clearance under number K941493 on June 22, 1994, under regulation 868.5140, confirming its substantial equivalence to a legally marketed predicate device for anesthesia conduction.