# K060549: Automobile Lighter Power Cord

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: May 4, 2006 after 63 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: 1 generation back to K905244 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905244: Model LP6 Ventilator, Modification, Aequitron Medical, Inc. (1990) Summary page 2.

## 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 Ilbs), 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/K060549
Methodology: https://510kreport.com/methodology