# K961476: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Jul 16, 1996 after 89 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
Longest line of descent: 1 generation back to K870027 (1987). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 1.

## Most influential descendants
- 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
- K051365: Compressor Nebulizer System, Model KN-9321 (2005), 1 descendant of its own
- K083256: Ultrasonic Nebulizer System, Model KN-9210 (2009), 0 descendants of its own
- K041974: MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer (2004), 0 descendants of its own

## Recalls of this device
- Aug 4, 2015 · Class II · Z-2781-2015: The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

## Indications for use
The Model 8960 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted. It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with nebulizers.

Source page: https://510kreport.com/device/K961476
Methodology: https://510kreport.com/methodology