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Standard Nebulizer Heater

by Seamless Div., Professional Medical Products

510(k) K895913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895913 Date22 Dec 1989ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Standard Nebulizer Heater is a medical device used for heating nebulizers. It is designed to work with nebulizers to provide a heated mist for inhalation. The device is classified under the product code CAF.

The Standard Nebulizer Heater is supplied by Seamless Div., Professional Medical Products, and has received FDA 510(k) clearance, indicated by the k number K895913. The device is intended for use in a medical setting, and its specifications and clearance type are listed as substantially equivalent and traditional, respectively.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Standard Nebulizer Heater used for?

    The Standard Nebulizer Heater is designed to heat nebulizers, producing a warm mist for inhalation therapy. This is particularly useful in medical settings where patients require humidified or heated aerosol treatments, such as respiratory care or post-operative recovery.

  • How is the Standard Nebulizer Heater supplied, and what distinguishes its model?

    The device is supplied by Seamless Div., Professional Medical Products and is uniquely identified by its FDA 510(k) clearance number K895913. It is classified under product code CAF and is intended for use with compatible nebulizers to deliver heated mist therapy.

  • Is the Standard Nebulizer Heater single-use or reusable?

    The device is not explicitly described as single-use or reusable in the provided data. However, given its design for medical settings and the nature of nebulizer heaters, it is typically intended for reusable clinical use with proper cleaning and maintenance between patients to ensure sterility and functionality.

  • What regulatory clearance does the Standard Nebulizer Heater hold?

    The Standard Nebulizer Heater holds FDA 510(k) clearance under the classification of substantially equivalent and traditional clearance type, with the advisory committee designation AN (Anesthesiology). The clearance number is K895913, filed in 1989 and decided upon in 1989.

  • Does the device require special storage conditions?

    The provided data does not specify storage requirements beyond standard medical device handling. For optimal performance and longevity, it is recommended to store the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and follow manufacturer guidelines for maintenance and cleaning if reused.