# K820227: Ster-O-Dose

- Pathway: 510(k) (Traditional)
- Applicant: Inhalation Therapy Equipment, Co.
- Decided: Feb 23, 1982 after 27 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 3 (3 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 5, 2017 · Class I · Z-0719-2019: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Sep 5, 2017 · Class I · Z-0721-2019: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Sep 5, 2017 · Class I · Z-0720-2019: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Source page: https://510kreport.com/device/K820227
Methodology: https://510kreport.com/methodology