Goodknight 425, Modelm-114500-00

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

510(k) Number

K041819 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Goodknight H20, Model M-114600-00

  Class II

  FDA 510(k) K042184 Active Cleared 10 Jan 2005

• Sandman Intro

  Class II

  FDA 510(k) K071575 Active Cleared 10 Sep 2007

• Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-Us; Sandman Info with Intergrate

  Class II

  FDA 510(k) K080439 Active Cleared 16 May 2008

• Knightcontrol Remote Control, Model M-114700-Us

  Class II

  FDA 510(k) K063501 Active Cleared 6 Apr 2007

• Puritan Bennett, Sandman Duo and Sandman Duo St

  Class II

  FDA 510(k) K082237 Active Cleared 9 Oct 2008

• Mallinckrodt, Goodknight 418S

  Class II

  FDA 510(k) K001845 Active Cleared 5 Jul 2000

• What is the Goodknight 425 ventilator (M-114500-00) used for?

  The Goodknight 425 ventilator (Model M-114500-00) is designed to provide mechanical ventilation for patients requiring respiratory support. It delivers controlled or assisted breaths to assist or replace spontaneous respiration, making it suitable for perioperative settings (e.g., operating rooms) and critical care under anesthesia supervision. Its primary purpose is to ensure adequate oxygenation and ventilation when patients cannot breathe adequately on their own.

• Is the Goodknight 425 ventilator (M-114500-00) single-use or reusable?

  The Goodknight 425 ventilator (M-114500-00) is intended for both single-use and reusable applications, depending on clinical protocols and institutional policies. Reuse requires adherence to manufacturer guidelines for cleaning, disinfection, and maintenance to ensure proper function and patient safety. Sterility status (sterile or non-sterile) should also align with the chosen use case.

• How should the Goodknight 425 ventilator (M-114500-00) be stored?

  Storage instructions for the Goodknight 425 ventilator (M-114500-00) are detailed in the accompanying manufacturer documentation. Generally, this includes protecting the device from physical damage, extreme temperatures, and contamination. If reusable, storage should follow protocols for clean, dry, and properly maintained equipment. Always refer to the provided guidelines to avoid compromising performance or regulatory compliance.

• What regulatory framework applies to the Goodknight 425 ventilator (M-114500-00)?

  The Goodknight 425 ventilator (M-114500-00) falls under 21 CFR 868.5905, the regulatory framework for ventilators, non-continuous (respirators). It holds FDA 510(k) clearance (K041819) as a Class II medical device under Special Controls, with no third-party involvement in its submission. The device was reviewed by the Anesthesiology (AN) Advisory Committee and classified under product code BZD.

• Can the Goodknight 425 ventilator (M-114500-00) be used in non-clinical environments?

  The Goodknight 425 ventilator (M-114500-00) is intended for controlled clinical environments such as operating rooms or intensive care units. Its design and regulatory classification (e.g., FDA 510(k)) assume use in settings where patient safety, sterility, and proper maintenance protocols can be strictly enforced. Non-clinical use may violate manufacturer guidelines and regulatory requirements.