# K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port

- Pathway: 510(k) (Traditional)
- Applicant: Diemolding Corp.
- Decided: Oct 10, 1996 after 87 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
2 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DHD TheraPEP: named in the summary without a submission number

## Most influential descendants
- K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device (1999), 11 descendants of its own
- K051964: Powerneb (2005), 7 descendants of its own
- K124032: Metaneb (2013), 6 descendants of its own
- K151689: MetaNeb 4 System (2016), 5 descendants of its own
- K991561: Roadrunner, Pep Therapy Device (1999), 5 descendants of its own

## Indications for use
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis.

Source page: https://510kreport.com/device/K962749
Methodology: https://510kreport.com/methodology