# K991355: Metered Dose Inhaler Adapter-Disposable,  Adapter Reusable

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Jan 27, 2000 after 283 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K091111: RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter Kit-Single Patient Use, Model RTC (2009), 2 descendants of its own
- K162753: RTC 26-C Inline Aerosol Adapter (2017), 0 descendants of its own
- K101953: SMDIA-1000 (2011), 0 descendants of its own
- K101857: RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-V (2010), 0 descendants of its own

## Indications for use
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use. The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.

Source page: https://510kreport.com/device/K991355
Methodology: https://510kreport.com/methodology