# K953976: Safe Micro

- Pathway: 510(k) (Traditional)
- Applicant: Polystan A/S
- Decided: Feb 4, 1997 after 531 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984322: Dideco D920, Lilliput 1 Twin Reservoir (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K953976
Methodology: https://510kreport.com/methodology