# K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Mar 18, 2009 after 96 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K902859 (1991). 59 ancestors in all.
2 later devices descend from it; 2 cite it directly.
5 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073694: Ivent 2001 Mri Conditional, Versamed Medical Systems, Inc. (2008) Summary page 2.

## Most influential descendants
- K240807: VM-2000 (2024), 0 descendants of its own
- K202970: Ventway Sparrow (2021), 0 descendants of its own

## Recalls of this device
- Jul 2, 2010 · Not classified · Z-2205-2010: CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have b

## Indications for use
The LTV® 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of the 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 5kg (11 lbs.), who require the following types of ventilatory support: · Positive Pressure Ventilation, delivered invasively (via endotrach tube or trach tube) or non-invasively (via mask or nasal prongs). · Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. The ventilator is suitable for use in institutional, home, or transport settings. The MR Conditional LTV® 1200 System is suitable for use in both 1.5 and 3.0 Tesla (not to exceed 3.0 Tesla static magnetic field) shielded magnetic scanners. CAUTION: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K083688
Methodology: https://510kreport.com/methodology