# K121623: Bipap a 40 Ventilatory Support System

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Dec 14, 2012 after 196 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K953930 (1996). 131 ancestors in all.
6 later devices descend from it; 1 cites it directly.
13 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113053: Bipap a 30 Ventilatory Support System, Respironics, Inc. (2012) Summary page 2.
- K093416: Trilogy 200 Ventilator, Respironics, Inc. (2010) Summary page 3.

## Most influential descendants
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own
- K233452: Vivo 45 LS (2025), 0 descendants of its own
- K241135: RESPOND (R) Ventilator (2024), 0 descendants of its own

## Recalls of this device
- May 9, 2025 · Class I · Z-2037-2025: This device does not indicate for use in patients with respiratory failure.
- Apr 1, 2024 · Class I · Z-1817-2024: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insuffi
- Jun 14, 2021 · Class I · Z-1958-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemic

## Indications for use
The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 Ibs) with Obstructive Sleep Apnea (GSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.

Source page: https://510kreport.com/device/K121623
Methodology: https://510kreport.com/methodology