# K981371: LTV 1000 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Oct 30, 1998 after 197 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: 1 generation back to K950484 (1996). 1 ancestor in all.
65 later devices descend from it; 6 cite it directly.
21 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950484: Tbird VS Ventilator and Tbird Avs Ventilator, Bird Products Corp. (1996) Summary page 1.

## Most influential descendants
- K040790: Modification to LTV 1000 Ventilator/Breathing Circuits (2004), 44 descendants of its own
- K060705: Carina Home (2006), 22 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K062267: Oxylog 3000 (2006), 20 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 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 1bs), 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 and transport settings.

Source page: https://510kreport.com/device/K981371
Methodology: https://510kreport.com/methodology