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Mistassist Breathing Exerciser

by The Merlin Corp.

510(k) K953055

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 NumberK953055 Date8 Feb 1996ClearedStatusActive

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  • Withdrawn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
BWF
Device Class
Class II
Regulation
21 CFR Part 868.5690
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Mistassist Breathing Exerciser is a therapeutic incentive spirometer designed to help patients perform breathing exercises. It assists in improving respiratory function by encouraging deep breathing and lung expansion.

This device is supplied by The Merlin Corp. and is classified as a Class II medical device. It has received FDA 510(k) clearance with product code BWF and is intended for use in anesthesiology settings. The device is not specified as single-use or reusable, and no MRI safety information is provided.

Other devices from The Merlin Corp.

  • Mistassist

    Class I

Questions

AI-generated answers, 23 Sep 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 Mistassist Breathing Exerciser used for?

    The Mistassist Breathing Exerciser is a therapeutic incentive spirometer designed to help patients perform breathing exercises, improving respiratory function by encouraging deep breathing and lung expansion in anesthesiology settings.

  • Is the Mistassist Breathing Exerciser single-use or reusable?

    The device is not specified as single-use or reusable in the available information, so users should refer to the manufacturer's instructions for proper handling and disposal guidelines.

  • What regulatory approvals does the Mistassist Breathing Exerciser have?

    The Mistassist Breathing Exerciser has received FDA 510(k) clearance with product code BWF and is classified as a Class II medical device, intended for use in anesthesiology settings.

  • How is the Mistassist Breathing Exerciser supplied?

    The Mistassist Breathing Exerciser is supplied by The Merlin Corp., and while specific packaging details aren't provided in the device data, it would be supplied according to standard medical device packaging protocols.