# K002763: Remrest

- Pathway: 510(k) (Traditional)
- Applicant: Medical Industries America, Inc.
- Decided: May 4, 2001 after 241 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 3, 2004 · Not classified · Z-0326-05: Units could show an error code and stop functioning.

Source page: https://510kreport.com/device/K002763
Methodology: https://510kreport.com/methodology