# K101857: RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-V

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Industries, Inc.
- Decided: Jul 22, 2010 after 20 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)
- 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)

## Indications for use
The Instrumentatioti Industries, Ittd. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP NMDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP 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-VP NMDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-VP MJDI Adapter 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/K101857
Methodology: https://510kreport.com/methodology