# K962534: Thera-Mist Nebulizer Model-P3000

- Pathway: 510(k) (Traditional)
- Applicant: Pegasus Research Corp.
- Decided: Feb 28, 1997 after 245 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K141214: Aquapak Nebulizer Adaptors/Reservoirs (2014), 1 descendant of its own
- K153010: Hudson RCI AquaPak Sterile Prefilled Nebulizers (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K962534
Methodology: https://510kreport.com/methodology