# K991788: Salter Labs Pep Device

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Aug 6, 1999 after 73 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
Longest line of descent: 1 generation back to K954492 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972042: Pari Pep Therapy System, Pari Holding Co. (1997) Summary page 3.
- K980725: Exhalation Valve (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-a), Instrumentation Industries, Inc. (1998) Summary page 3.
- K954492: Mercury Medical Expiratory Resistance Exerciser, Resistex, Mercury Medical (1996) Summary page 3.

## Indications for use
This product is indicated for use in patients where enhanced medicated aerosol deposition or lung exercise is recommended by a physician or licensed clinician. This device is intended to be used in the hospital, clinic and home care markets, The Salter Labs PEP device is designed to be used with the Salter Labs Nebutech Nebulizer-series Mouthpiece as a stand-alone device, or the device may be used in conjunction with the Salter Labs Nebutech Nebulizer and the Salter Labs Aerosol Filter during the nebulization process. This product is a nebulizer accessory that connects to the exhalation port of the Salter Labs Nebutech Nebulizer mouthpiece and serves to provide a controllable exhalation resistance of from 5 to 20 cm H20 at flow rates ranging from 10 to 55 L/min,

Source page: https://510kreport.com/device/K991788
Methodology: https://510kreport.com/methodology