# K905235: VDR Sinusoidal Percusionator Family/Relate Access

- Pathway: 510(k) (Traditional)
- Applicant: Percussionaire Corp.
- Decided: May 3, 1991 after 177 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (2 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.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Dec 23, 2024 · Class I · Z-0960-2025: Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
- Mar 28, 2023 · Class I · Z-0693-2024: Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- Sep 14, 2020 · Class II · Z-0259-2024: Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to instal

Source page: https://510kreport.com/device/K905235
Methodology: https://510kreport.com/methodology