Nebulo 28 Nebulizer Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K841158 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Manifold & Nebu. for Single Line Mach.

  Class II

  FDA 510(k) K772071 Active Cleared 15 Nov 1977

• Pediatric Anesthesia Circuit

  Class I

  FDA 510(k) K770549 Active Cleared 30 Mar 1977

• Filter, Bacteria (#2290)

  Class II

  FDA 510(k) K760081 Active Cleared 15 Jul 1976

• Inspiron Liquid Oxygen System

  Class II

  FDA 510(k) K834290 Active Cleared 4 Feb 1984

• Cannula, Nasal, for Oxygen

  Class I

  FDA 510(k) K760080 Active Cleared 15 Jul 1976

• Vapor-Phase Humidifier Sys-Advanced

  Class II

  FDA 510(k) K843932 Active Cleared 18 Oct 1984

See all devices from Inspiron Corp. →

• What is the Nebulo 28 Nebulizer Kit used for?

  The Nebulo 28 Nebulizer Kit is designed to convert liquid medication into a fine aerosol mist, enabling direct inhalation therapy. This is particularly useful for treating respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), or other disorders requiring nebulized medication delivery. The device facilitates targeted treatment by delivering therapeutic agents straight to the respiratory tract.

• Is the Nebulo 28 Nebulizer Kit intended for single-use or reuse?

  The Nebulo 28 Nebulizer Kit is explicitly intended for single-use only in both clinical and home settings. It is supplied sterile within its manufacturer-provided packaging, eliminating the need for additional sterilization or reprocessing. This design ensures patient safety and hygiene by preventing cross-contamination.

• How is the Nebulo 28 Nebulizer Kit supplied, and what does the kit include?

  The Nebulo 28 Nebulizer Kit is supplied as a complete, ready-to-use unit in its original packaging. No additional components or accessories are required beyond what is included in the kit. The device is pre-sterilized by the manufacturer, so no further sterilization steps are necessary before use.

• Does the Nebulo 28 Nebulizer Kit require any special storage conditions?

  The provided data does not specify any special storage conditions (e.g., temperature, humidity, or light exposure) for the Nebulo 28 Nebulizer Kit. However, standard medical device storage practices—such as keeping it in a clean, dry environment and protecting it from physical damage—are recommended. Always follow the manufacturer’s instructions if additional guidance is provided elsewhere.

• What regulatory clearance does the Nebulo 28 Nebulizer Kit hold?

  The Nebulo 28 Nebulizer Kit holds an FDA 510(k) clearance (K841158) under the BTT product code. This clearance indicates that the device is classified as Substantially Equivalent to a predicate device and meets FDA requirements for safety and effectiveness as a Class II medical device. The clearance was issued in 1984, and no additional regulatory details beyond this are provided in the available data.