# K981249: Metered Dose Inhaler-Reusable Model Number RTC 21-a, Metered Dose Inhaler-Disposable Model Nuber RTC 21-D

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Nov 23, 1998 after 231 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The RTC 21 Series MDI adapters are intended for use in intermittent aerosol therapy to deliver aerosol medications (in compressed cannister MDISs) via the proximal end of an endotracheal tube.

Source page: https://510kreport.com/device/K981249
Methodology: https://510kreport.com/methodology