# K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Apr 5, 2011 after 180 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 9 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K833786 (1983). 18 ancestors in all.
4 later devices descend from it; 2 cite it directly.
3 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082660: V60 Ventilator, Model V8000, Respironics California, Inc. (2009) Summary page 1.

## Most influential descendants
- K213521: Nihon Kohden NKV-330 Ventilator System (2022), 2 descendants of its own
- K252182: SV70 Ventilator (SV70) (2026), 0 descendants of its own
- K242931: HFT750U (2025), 0 descendants of its own
- K230173: Servo-air Lite Ventilator System (2023), 0 descendants of its own

## Recalls of this device
- Aug 25, 2023 · Class I · Z-2631-2023: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
- Feb 28, 2022 · Class I · Z-0908-2022: Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
- Feb 28, 2022 · Class I · Z-0907-2022: Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.
- Jan 24, 2022 · Class I · Z-0662-2022: A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop 
- Jan 24, 2022 · Class I · Z-0663-2022: A limited number of ventilators were assembled with expired adhesive. If the adhesive fails, a bracket may become loose and potentially damage the capacitors, which could cause the ventilator to stop 
- Apr 24, 2017 · Class I · Z-2061-2017: Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high 
- Feb 1, 2017 · Class II · Z-1687-2017: The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor has stalled. If this condition occurs, the software will cause the ventilator to shut down (Vent Inop) 
- Jun 4, 2013 · Class I · Z-1537-2013: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management
- Jul 31, 2012 · Class I · Z-2260-2012: Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blo

## Indications for use
The V60 Ventilator with Proportional Pressure Ventilation and Auto-Trak+ Software Options is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional setting under the direction of a physician. The ventilator is intended to support pediatric patients weighing 20 kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

Source page: https://510kreport.com/device/K102985
Methodology: https://510kreport.com/methodology