# K101953: SMDIA-1000

- Pathway: 510(k) (Traditional)
- Applicant: Southmedic, Inc.
- Decided: Jan 7, 2011 after 179 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991355 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991355: Metered Dose Inhaler Adapter-Disposable,  Adapter Reusable, Instrumentation Industries, Inc. (2000) Summary page 1.
- K091111: RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter Kit-Single Patient Use, Model RTC, Instrumentation Industries, Inc. (2009) Summary page 1.

## Indications for use
The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes. The SMDIA-1000 MDI adaptor is single patient use, disposable.

Source page: https://510kreport.com/device/K101953
Methodology: https://510kreport.com/methodology