# K974176: Babylog 8000 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Jun 17, 1998 after 223 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: 1 generation back to K902859 (1991). 2 ancestors in all.
151 later devices descend from it; 7 cite it directly.
45 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926292: Babylog 8000 Infant Ventilator, Drager, Inc. (1994) Summary page 3.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 3.

## Most influential descendants
- K992788: Bear Cub 750 PSV (1999), 134 descendants of its own
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own

## Recalls of this device
- Dec 28, 2005 · Not classified · Z-0515-06: Failure to generate an alarm when an unintended disconnection occurrs

## Indications for use
The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 Ibs). The device provides the following ventilation modes: CMV Continuous Mandatory Ventilation Time-controlled, time-cycled, pressure-limited continuous flow ventilation. A/C Assist Control Ventilation Time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation that is synchronized with each spontaneous patient breath. SIMV Synchronized Intermittent Mandatory Ventilation Time-controlled, volume triggered, flow cycled, pressure-limited continuous flow ventilation, synchronized with patient's spontaneous breathing at the set ventilation rate. PSV Pressure Support Ventilation (available option) Time-controlled, volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath. CAP Ccontinuous Positive Airway Pressure Spontaneous breathing with positive airway pressure Ventilation mode extension: VG Volume Guarantee (available option), Volume controlled ventilation. The ventilator controls inspiratory pressure in order to deliver the preset tidal volume. May be combined with A/C; SIMV and PSV. VIVE Variable Inspiratory, Variable Expiratory Flow Separate continuous flow during expiration in mandatory ventilation modes.

Source page: https://510kreport.com/device/K974176
Methodology: https://510kreport.com/methodology