# K972894: Autotransfusion Appartus (Autolog)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Blood Management
- Decided: Apr 27, 1998 after 265 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sequestra: named in the summary without a submission number
- (no number) ELMD 500 autotransfusion apparatus: named in the summary without a submission number

## Most influential descendants
- K982755: Modification of Autotransfusion Apparatus (Autolog) (1998), 2 descendants of its own
- K093535: Autolog Autotransfusion System (2010), 1 descendant of its own
- K181954: autoLog IQ Autotransfusion System (2018), 0 descendants of its own
- K060482: Cytori Celution Cell Concentration Device (2006), 0 descendants of its own

## Recalls of this device
- Apr 21, 2010 · Not classified · Z-1939-2010: The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no repor

## Indications for use
The autoLog™ is intended for use in the collection, concentration, washing, and reinfusion of autologous blood. Such areas of application may include, but are not limited to, the following: General, Cardiovascular, Orthopedic, Vascular, Plastic/Reconstructive, Obstetric/Gynecologic and Neurosurgical Postoperative treatment areas

Source page: https://510kreport.com/device/K972894
Methodology: https://510kreport.com/methodology