# K111570: Minispacer (R) Mdi Adapter with Counter Incrementing Actuator

- Pathway: 510(k) (Traditional)
- Applicant: Thayer Medical Corporation
- Decided: Sep 29, 2011 after 115 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K233553: MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (2024), 0 descendants of its own

## Recalls of this device
- Sep 29, 2016 · Class II · Z-1146-2017: The insert and case label description of the device incorrectly reads Counter Incrementing Actuator with 22mm O.D./I.D. Connections.

## Indications for use
The MINISPACER® 1024A, 1025A and 1543A adapters are single patient, disposable devices for dispensing pressurized metered dose inhaler (pMDI) medication into a breathing circuit, as prescribed by a physician or other licensed health care practitioner. The MINISPACER® 1024A, 1025A and 1543A adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments.

Source page: https://510kreport.com/device/K111570
Methodology: https://510kreport.com/methodology