# K984407: Bipap Harmony S/T, Model 1001445

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: May 19, 1999 after 161 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K962517 (1997). 1 ancestor in all.
115 later devices descend from it; 2 cite it directly.
32 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962517: Model 7700 Quantum Pressure Support Ventilator PSV, Healthdyne Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K022132: Servo Ventilator System, Model 64 87 800 E407E (2002), 102 descendants of its own
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own

## Indications for use
The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.

Source page: https://510kreport.com/device/K984407
Methodology: https://510kreport.com/methodology