# K920121: Sechrist IV-100B Savi System

- Pathway: 510(k) (Traditional)
- Applicant: Sechrist
- Decided: Feb 1, 1993 after 385 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K062793: Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option (2007), 0 descendants of its own

## Recalls of this device
- May 20, 2004 · Not classified · Z-1032-04: Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.

Source page: https://510kreport.com/device/K920121
Methodology: https://510kreport.com/methodology