# K091111: RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter Kit-Single Patient Use, Model RTC

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Dec 2, 2009 after 229 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: 1 generation back to K991355 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 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.

## Most influential descendants
- 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 Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style, metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-V MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician. The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long tenn or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V M4DI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.

Source page: https://510kreport.com/device/K091111
Methodology: https://510kreport.com/methodology