# K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Mar 16, 1987 after 70 days
- Product code: CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer))
- Device class: 1
- Regulation: 21 CFR 868.5640
- 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.
16 later devices descend from it; 6 cite it directly.
0 of 17 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
- K961476: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984) (1996), 6 descendants of its own
- K014056: Salter Labs Modified Nebutech Nebulizer (2002), 5 descendants of its own
- K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow) (2004), 4 descendants of its own
- K962879: Salterlabs 8660 Series Nebulizer (1996), 4 descendants of its own
- K123527: Airlife (2013), 1 descendant of its own

## Recalls of this device
- Mar 25, 2011 · Not classified · Z-0108-2012: A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.

Source page: https://510kreport.com/device/K870027
Methodology: https://510kreport.com/methodology