# K013038: Safe Maxi Hollow Fiber Oxygenator, Model 016010

- Pathway: 510(k) (Traditional)
- Applicant: Polystan A/S
- Decided: Aug 14, 2002 after 338 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
Longest line of descent: 2 generations back to K932252 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992559: Hollow Fiber Membrane Oygenator Quadrox Hmo 1010, Jostra Bentley (1999) Summary page 1.

## Indications for use
The SAFE MAXI - hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K013038
Methodology: https://510kreport.com/methodology