# K051284: MD Turbo

- Pathway: 510(k) (Traditional)
- Applicant: Respirics, Inc.
- Decided: Jun 22, 2005 after 40 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 K872037 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992038: Pocketspacer, Ferraris Medical, Inc. (1999) Summary page 1.
- K935955: DOSER, Newmed Corp. (1994) Summary page 1.
- K960593: Smartmist Asthma Managment System, Smartmist, Model Number SM-100/Smartmist Spirometry Airway, Model Number SA-100, Aradigm Corp. (1996) Summary page 1.

## Indications for use
MD TurboTM is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo TM is also intended for use by patients to count the number of doses remaining in their pMDI.

Source page: https://510kreport.com/device/K051284
Methodology: https://510kreport.com/methodology