# P890057: Model 3100 Frequency Oscillatory Ventilator

- Pathway: PMA
- Applicant: ZOLL Medical Corporation
- Decided: Mar 29, 1991 after 541 days
- Product code: LSZ (Ventilator, High Frequency)
- Device class: 3
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 27, 2023 · Class II · Z-0488-2024: Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Source page: https://510kreport.com/device/P890057
Methodology: https://510kreport.com/methodology