# K162738: Puritan Bennett 980 Ventilator System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Oct 27, 2017 after 392 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K902859 (1991). 78 ancestors in all.
1 later device descends from it; 1 cites it directly.
10 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131252: Puritan Bennett 980 Series Ventilator System, Covidien (2014) Summary page 4.

## Most influential descendants
- K193056: Puritan Bennett 980 Series Ventilator System (2020), 0 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0425-2021: In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or b
- Sep 18, 2018 · Class I · Z-0497-2019: Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation

## Indications for use
The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support - Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or non-invasively (via mask or nasal prongs) - Assist/Control, SIMV, or Spontaneous modes of ventilation

Source page: https://510kreport.com/device/K162738
Methodology: https://510kreport.com/methodology