# K983467: Therapep

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Apr 2, 1999 after 189 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
Longest line of descent: 1 generation back to K954492 (1996). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954492: Mercury Medical Expiratory Resistance Exerciser, Resistex, Mercury Medical (1996) Summary page 1.

## Most influential descendants
- K991561: Roadrunner, Pep Therapy Device (1999), 5 descendants of its own
- K140772: Aerosure Medic (2014), 1 descendant of its own
- K233855: AllPEP (2024), 0 descendants of its own
- K203378: Pulsehaler (2021), 0 descendants of its own
- K160636: iPEP System and vPEP (2016), 0 descendants of its own

## Indications for use
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.

Source page: https://510kreport.com/device/K983467
Methodology: https://510kreport.com/methodology