# K874597: Thermovent 600, 1200, T, 02

- Pathway: 510(k) (Traditional)
- Applicant: Portex, Inc.
- Decided: Jan 19, 1988 after 71 days
- Product code: BYD (Condenser, Heat And Moisture (Artificial Nose))
- Device class: 1
- Regulation: 21 CFR 868.5375
- Recalls of this device: 3 (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
- Jul 13, 2004 · Not classified · Z-1131-04: Sterility of the device is compromised due to lack of package integrity
- Jul 13, 2004 · Not classified · Z-1129-04: Sterility of the device is compromised due to lack of package integrity
- Jul 13, 2004 · Not classified · Z-1130-04: Sterility of the device is compromised due to lack of package integrity

Source page: https://510kreport.com/device/K874597
Methodology: https://510kreport.com/methodology