# K833982: Model IV 100B-DA Infant Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Sechrist Industries, Inc.
- Decided: Mar 5, 1984 after 109 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.
25 later devices descend from it; 2 cite it directly.
9 of 26 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
- K031745: Infant Flow Plus Infant Cpap System with Sipap Function (2004), 22 descendants of its own
- K062093: Avea Ventilator (2006), 21 descendants of its own
- K081521: Modification to Hamilton-G5 (2008), 16 descendants of its own
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- K112006: Hamilton-TC1 (2012), 13 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/K833982
Methodology: https://510kreport.com/methodology