# K992038: Pocketspacer

- Pathway: 510(k) (Traditional)
- Applicant: Ferraris Medical, Inc.
- Decided: Sep 9, 1999 after 85 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Respiratory Delivery System’s MicroChamber: named in the summary without a submission number

## Most influential descendants
- K051284: MD Turbo (2005), 0 descendants of its own

## Indications for use
The PocketSpacer is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

Source page: https://510kreport.com/device/K992038
Methodology: https://510kreport.com/methodology