# K060647: LTV 1200 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: May 25, 2006 after 73 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902859 (1991). 36 ancestors in all.
29 later devices descend from it; 9 cite it directly.
16 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011957: Ivent 201 Portable Ventilator, Versamed, Ltd. (2001) Summary page 2.
- K022674: Bird Avea Ventilator, Bird Products Corp. (2002) Summary page 2.
- K051767: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), 12 descendants of its own
- K133868: Astral Ventilator (2014), 10 descendants of its own
- K160481: Vivo 60 (2016), 7 descendants of its own
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own
- K091238: Uni-Vent-731 Series Ventilators, Model 731EMV+ (2009), 6 descendants of its own

## Indications for use
The LTV 1200 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, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings.

Source page: https://510kreport.com/device/K060647
Methodology: https://510kreport.com/methodology