# K991300: Boeing, Positive Airway Pressure (Pap) Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Jul 12, 1999 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
Longest line of descent: 1 generation back to K944900 (1995). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962749: Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask, Resistor/Port/Mouthpiece, Resistor/Port, Diemolding Corp. (1996) Summary page 1.
- K944900: Therapep, Dhd Diemolding Healthcare Div. (1995) Summary page 1.

## Most influential descendants
- 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
- K192143: Maximus System (2020), 4 descendants of its own
- K200988: Maximus System (2020), 3 descendants of its own

## Indications for use
Boeing is indicated for the treatment and prevention of atelectasis. Boeing facilitates opening of airways in patients requiring prevention or treatment of atelectasis. Boeing also has the ability to provide supplemental oxygen when used with compressed oxygen. Patients requiring therapy for treatment and prevention of atelectasis who are capable of following directions for Positive Airway Pressure (PAP) therapy. 3.1. Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the order of a physician.” 3.2. Boeing is intended for use in a hospital.

Source page: https://510kreport.com/device/K991300
Methodology: https://510kreport.com/methodology