Minispacer MDI Adapter with Counter Incrementing Actuator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111570 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Minispacer MDI Adapter with Counter Incrementing Actuator is a medical device used for administering MDI medication to ventilated patients. It is designed to be placed in various locations within the patient circuit. The device has a counter incrementing actuator, which suggests it can track the number of doses administered. As an MDI adapter, it is intended to facilitate the delivery of medication from a metered dose inhaler.
The Minispacer MDI Adapter with Counter Incrementing Actuator is supplied with a specific configuration, and it has been authorized with an FDA 510K clearance. The device is associated with the product code CAF and has been reviewed by the Anesthesiology advisory committee. It is available in different configurations, although specific sizes are not detailed in the provided data. The device is designed for use in respiratory care settings, including with ventilated patients and potentially in conjunction with a resuscitator bag.
Frequently asked questions
What is the Minispacer MDI Adapter used for?
The Minispacer MDI Adapter with Counter Incrementing Actuator is used for administering MDI medication to ventilated patients, facilitating delivery from a metered dose inhaler.
Is the Minispacer MDI Adapter supplied in different configurations?
Yes, the Minispacer MDI Adapter with Counter Incrementing Actuator is available in different configurations, although specific sizes are not detailed.
How does the Counter Incrementing Actuator work?
The Counter Incrementing Actuator tracks the number of doses administered, providing a way to monitor medication delivery.
In what settings is the Minispacer MDI Adapter intended for use?
The Minispacer MDI Adapter with Counter Incrementing Actuator is designed for use in respiratory care settings, including with ventilated patients and potentially in conjunction with a resuscitator bag.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The original Valved Tee™ Adapter | Thayer Medical, N: Thayer Medical, Thayer Medical | Products for Respiratory Care | MDI Holding Chambers ..., MiniSpace Dual-Spray MDI Adapters | Medline Industries, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111570 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thayer Medical Corporation
Sources (1)
- FDA 510(k) K111570 24 fields · synced Sep 28, 2026