# K980974: Safe Mini

- Pathway: 510(k) (Traditional)
- Applicant: Polystan A/S
- Decided: Oct 13, 2000 after 942 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022281: Safe Maxi Venous/Cardiotomy Reservior, Model 016045 (2002), 0 descendants of its own

## Indications for use
The SAFE MINT hollow fibre oxygenater is intended for use in an extracorporeal circwit 4o oXygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration. The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

Source page: https://510kreport.com/device/K980974
Methodology: https://510kreport.com/methodology