# K113053: Bipap a 30 Ventilatory Support System

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Feb 1, 2012 after 111 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K953930 (1996). 111 ancestors in all.
8 later devices descend from it; 2 cite it directly.
10 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092818: Bipap Avaps Ventilatory Support System, Respironics, Inc. (2010) Summary page 2.
- K082660: V60 Ventilator, Model V8000, Respironics California, Inc. (2009) Summary page 2.
- K103167: Stellar 150, Resmed Germany, Inc. (2011) Summary page 2.

## Most influential descendants
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K252078: BreathePal Bilevel  (GFM50-MD2201) (2026), 0 descendants of its own
- K232365: Vivo 45 LS (2025), 0 descendants of its own

## Recalls of this device
- May 9, 2025 · Class I · Z-2036-2025: This device does not indicate for use in patients with respiratory failure.
- Aug 26, 2022 · Class I · Z-1654-2022: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Jun 14, 2021 · Class I · Z-1957-2021: 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
- 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
- Jun 14, 2021 · Class I · Z-1973-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain c

## Indications for use
The BiPAP A30 ventilator is intended to provide non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (221bs) with Obstructive Sleep Apnea (OSA and Respiratory Insufficiency. It is intended to be used in both the home and clinical settings, such as hospitals, sleep laboratories, and sub-acute care institutions.

Source page: https://510kreport.com/device/K113053
Methodology: https://510kreport.com/methodology