# K070594: Palmtop Ventilator, Models PTV-8, PTV-10

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonetic Systems, Inc.
- Decided: Aug 1, 2007 after 152 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K902859 (1991). 55 ancestors in all.
12 later devices descend from it; 3 cite it directly.
11 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060647: LTV 1200 Ventilator, Pulmonetic Systems, Inc. (2006) Summary page 3.
- K981371: LTV 1000 Ventilator, Pulmonetic Systems, Inc. (1998) Summary page 3.
- K984056: LTV 1000, Pulmonetic Systems, Inc. (1999) Summary page 3.
- K021981: Ivent 201 Portable Ventilator, Versamed, Ltd. (2003) Summary page 3.
- K032451: Bird Tbird Vela Ventilator, Bird Products Corp. (2004) Summary page 3.

## Most influential descendants
- K162877: VOCSN Unified Respiratory System (2017), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K090888: Newport HT70 Family of Ventilators (2009), 2 descendants of its own
- K162832: 731 Series Ventilators (2017), 1 descendant of its own

## Recalls of this device
- Aug 8, 2014 · Class I · Z-2593-2014: CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters
- Jun 19, 2012 · Class I · Z-2006-2012: CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The
- Sep 12, 2011 · Not classified · Z-0074-2012: CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient
- Jan 8, 2010 · Not classified · Z-0857-2010: CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory envir

## Indications for use
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. Federal law (USA) restricts the sale of this device except by or on the order of a physician.

Source page: https://510kreport.com/device/K070594
Methodology: https://510kreport.com/methodology