# K984586: Fresenius ATR40 and ATR120 Autotransfusion Reservoirs

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Hemotechnology, Inc.
- Decided: Jun 29, 1999 after 187 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K802674 (1981). 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)
- K802674: Reservoir for Autologous Blood Transfus., Haemonetics Corp. (1981) Summary page 2.
- K915737: Autotransfusion Blood Collection Reservoir, Electromedics, Inc. (1992) Summary page 2.

## Indications for use
The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect defoam, filter, and store blood prior to processing.

Source page: https://510kreport.com/device/K984586
Methodology: https://510kreport.com/methodology