# K884947: Hand Held Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Feb 17, 1989 after 84 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have 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.

## Most influential descendants
- K052811: Hsiner Jet Nebulizer, Model HS-31100 (2005), 4 descendants of its own
- K091272: Besmed Jet Nebulizer Bottle Set (2009), 1 descendant of its own
- K070948: Hsiner Nebulizer Bottle (2007), 1 descendant of its own
- K212395: Nebulizer (2022), 0 descendants of its own
- K082009: Hsiner Nebulizer Bottle, CPR Masks and Face Shields (2008), 0 descendants of its own

## Recalls of this device
- Jan 5, 2016 · Class II · Z-0796-2016: Reports that the T-piece does not fit on the nebulizer.

Source page: https://510kreport.com/device/K884947
Methodology: https://510kreport.com/methodology