# K991561: Roadrunner, Pep Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Nov 10, 1999 after 190 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: 2 generations back to K954492 (1996). 6 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944900: Therapep, Dhd Diemolding Healthcare Div. (1995) Summary page 1.
- K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port, Diemolding Corp. (1996) Summary page 1.
- K983467: Therapep, Dhd Healthcare Corp. (1999) Summary page 1.
- K940986: Flutter (R), Varioraw SA (1994) Summary page 1.
- K946083: Flutter (R), Bradstreet Clinical Research Assoc., Inc. (1995) Summary page 1.

## Most influential descendants
- 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
- K133057: Vibralung Acoustical Percussor (2014), 0 descendants of its own

## Indications for use
1 - Purpose: The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device. 2 - Claims: = The use of DHD Roadrunner improves clearance of secretions » The use of DHD Roadrunner may reduce the need for postural drainage * DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems = The DHD Roadrunner may be used to prevent or reverse atelectasis 3 - Target Patient Population Patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy. 4 - Intended Environment For Use = Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the order of a physician.” = May be used in hospital as well as the home after a period of training.

Source page: https://510kreport.com/device/K991561
Methodology: https://510kreport.com/methodology