# K082660: V60 Ventilator, Model V8000

- Pathway: 510(k) (Traditional)
- Applicant: Respironics California, Inc.
- Decided: Jan 9, 2009 after 119 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 44 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K833786 (1983). 17 ancestors in all.
14 later devices descend from it; 3 cite it directly.
7 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 1.
- K070328: Bipap Synchrony with Avaps, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K981072: Esprit Ventilator, Respironics, Inc. (1998) Summary page 1.

## Most influential descendants
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options (2011), 4 descendants of its own
- K213521: Nihon Kohden NKV-330 Ventilator System (2022), 2 descendants of its own

## Recalls of this device
- Jan 6, 2021 · Class II · Z-1137-2021: Due to unqualified "design verification" batteries being shipped to customers.
- Nov 2, 2020 · Class II · Z-0902-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0903-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0906-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0911-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0915-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0916-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0907-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0904-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0905-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0910-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0914-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0908-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0909-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0912-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0913-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Nov 2, 2020 · Class II · Z-0917-2021: Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator para
- Oct 30, 2020 · Class II · Z-0886-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0885-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0889-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0890-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0892-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0893-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0895-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0896-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0898-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0887-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0888-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0891-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0894-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0897-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0899-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0900-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Oct 30, 2020 · Class II · Z-0901-2021: Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without be
- Mar 5, 2020 · Class II · Z-1622-2020: Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm
- Sep 11, 2019 · Class II · Z-1155-2020: Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore
- Sep 11, 2019 · Class II · Z-1154-2020: Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore
- Sep 11, 2019 · Class II · Z-1152-2020: Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefor
- Sep 11, 2019 · Class II · Z-1153-2020: Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore
- 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 
- 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
- Jul 2, 2010 · Not classified · Z-0457-2011: Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal da
- Oct 26, 2009 · Not classified · Z-0176-2010: The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become d

## Indications for use
The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) 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/K082660
Methodology: https://510kreport.com/methodology