45DEGREES Swivel Elbow

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811922 ↗

FDA Product Code

BZA

Device Class

Class I

Regulation

21 CFR Part 868.5810

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• T-Pieces Connectors

  Class I

  FDA 510(k) K860887 Active Cleared 19 Mar 1986

• Nasal Cannula W/2M & 5M Tubing

  Class I

  FDA 510(k) K860872 Active Cleared 19 Mar 1986

• Inspiratory Force Mont Kit/Manifold/Meter/Tubing

  Class II

  FDA 510(k) K873498 Active Cleared 9 Mar 1988

• Asthmakit

  Class II

  FDA 510(k) K874047 Active Cleared 29 Feb 1988

• Non-Rebreathing T Piece

  Class II

  FDA 510(k) K790820 Active Cleared 4 May 1979

• HOO2D Seat-Infant

  Class I

  FDA 510(k) K820640 Active Cleared 26 Mar 1982

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