# K010925: Servoi Ventilator System, Model 64 87 800 E407E

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Elema AB
- Decided: Dec 18, 2001 after 266 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
No predicates in its family tree.
104 later devices descend from it; 4 cite it directly.
32 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022132: Servo Ventilator System, Model 64 87 800 E407E (2002), 102 descendants of its own
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K022679: Raphael (2003), 54 descendants of its own

## Recalls of this device
- May 23, 2006 · Not classified · Z-0372-2007: Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when 

Source page: https://510kreport.com/device/K010925
Methodology: https://510kreport.com/methodology