# K970839: Servo Ventilator 300A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Elema AB
- Decided: Oct 14, 1997 after 221 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902859 (1991). 2 ancestors in all.
171 later devices descend from it; 8 cite it directly.
49 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960010: Servo Ventilator 300 Computer Interface, Siemens Elema AB (1996) Summary page 1.

## Most influential descendants
- K993449: Bird V.I.P. Gold/Sterling (1999), 134 descendants of its own
- 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

## Recalls of this device
- Nov 17, 2009 · Not classified · Z-0588-2010: Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damag
- Mar 23, 2009 · Not classified · Z-1252-2009: The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails.
- Dec 19, 2008 · Not classified · Z-0872-2009: SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short s
- Jan 3, 2005 · Not classified · Z-0571-05: Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

## Indications for use
Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician), when the professional determines that a device is required to assist the breathing of the patient. The device can be used both for controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability.

Source page: https://510kreport.com/device/K970839
Methodology: https://510kreport.com/methodology