# K984056: LTV 1000

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Apr 12, 1999 after 150 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K841279 (1984). 4 ancestors in all.
40 later devices descend from it; 7 cite it directly.
16 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981971: Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with Pressure Limit Model 00-004130, Bear 3, Bird Products Corp. (1998) Summary page 1.

## Most influential descendants
- K022750: PLV Continuum Ventilator, Model P1000 (2003), 29 descendants of its own
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), 12 descendants of its own
- K111610: Trilogy Series Ventilator with Oximetry (2011), 11 descendants of its own

## Recalls of this device
- Feb 22, 2008 · Not classified · Z-1463-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1469-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1468-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1467-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1464-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1470-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1466-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Feb 22, 2008 · Not classified · Z-1465-2008: The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
- Nov 9, 2005 · Not classified · Z-0184-06: Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in f
- Nov 9, 2005 · Not classified · Z-0186-06: Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in f
- Nov 9, 2005 · Not classified · Z-0185-06: Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in f
- Sep 8, 2004 · Not classified · Z-1485-04: Ventilators have not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power. This situation results in loss of ventilation t

## Indications for use
The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ibs), who require the following types of ventilatory support: * Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). * Assist/Control, SIMV, or CPAP modes of ventilation. The ventilator is suitable for use in institutional, home, and transport settings.

Source page: https://510kreport.com/device/K984056
Methodology: https://510kreport.com/methodology