# K162877: VOCSN Unified Respiratory System

- Pathway: 510(k) (Traditional)
- Applicant: Ventec Life Systems, Inc.
- Decided: Apr 7, 2017 after 175 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 16 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K902859 (1991). 88 ancestors in all.
6 later devices descend from it; 1 cites it directly.
12 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111610: Trilogy Series Ventilator with Oximetry, Respironics, Inc. (2011) Summary page 5.
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10, Pulmonetic Systems, Inc. (2007) Summary page 5.
- K120785: Omni 3 Oxygen System, Caire, Inc. (2012) Summary page 5.
- K121955: Coughassist T70 Device, Respironics, Inc. (2012) Summary page 5.
- K140179: Easy GO Vac, Precision Medical, Inc. (2014) Summary page 5.

## 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
- Sep 17, 2026 · Class I · Z-0129-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0130-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0127-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0124-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0131-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0123-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0128-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0125-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0126-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0122-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- Sep 17, 2026 · Class I · Z-0132-2027: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
- May 8, 2026 · Class II · Z-2525-2026: Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activat
- Mar 25, 2026 · Class I · Z-1942-2026: Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak 
- Feb 3, 2025 · Class I · Z-1196-2025: Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, n
- Jan 9, 2024 · Class I · Z-1070-2024: The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance result
- May 10, 2021 · Class II · Z-1902-2021: Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation t

## Indications for use
The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

Source page: https://510kreport.com/device/K162877
Methodology: https://510kreport.com/methodology