# K962879: Salterlabs 8660 Series Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Oct 22, 1996 after 90 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.
4 later devices descend from it; 3 cite 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)
- K870027: Hand Held Pheumatic Powered (Disposable) Nebulizer, Salter Labs (1987) Summary page 1.

## Most influential descendants
- K123527: Airlife (2013), 1 descendant of its own
- K230602: Hudson RCI® TurboMist™ Nebulizer System (2023), 0 descendants of its own
- K080969: Healthline Redi-Neb Medication Nebulizer, Model RN-510 (2008), 0 descendants of its own
- K062484: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers (2007), 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 8660 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 reusable single patient use device (whereas the 8900 is a disposable single patient use 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, although it must be cleaned or disinfected per the label instructions before reuse. The device is for single patient use. It is intended to be used with accessories, such tubing which is an industry standard device used with nebulizers.

Source page: https://510kreport.com/device/K962879
Methodology: https://510kreport.com/methodology