# K002881: Ventilator, Continuous (Respirator), Model LTV 1000

- Pathway: 510(k) (Special)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Oct 11, 2000 after 26 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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.
- 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

Source page: https://510kreport.com/device/K002881
Methodology: https://510kreport.com/methodology