# K040540: Modification to LTV 1000 Ventilator

- Pathway: 510(k) (Special)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Apr 29, 2004 after 58 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 8 (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). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032226: LTV-1000 Ventilator, Pulmonetic Systems, Inc. (2003) Summary page 2.
- 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 2.

## Most influential descendants
- K082724: Newport HTS50 Ventilator with Dual Pac Battery System (2008), 9 descendants of its own
- K100753: Flight 60 Ventilator, Model F-60 (2010), 5 descendants of its own
- K111683: Flight 60 Ventilator (2011), 4 descendants of its own
- K120726: Flight 60 Ventilator (2012), 3 descendants of its own
- K130171: Flight 60 Ventilator (2014), 2 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.

## Indications for use
The LTV 1000 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 5 kg (11 lbs.), 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, or transport settings.

Source page: https://510kreport.com/device/K040540
Methodology: https://510kreport.com/methodology