# K041525: Hemovac Blood Reinfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 14, 2004 after 128 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- 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 K914119 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920273: Hemovac Autotransfusion System, Zimmer Patient Care Division (1993) Summary page 1.
- K952224: Stryker Constavac Blood Conservation System II (Cbcii), Stryker Instruments (1995) Summary page 1.
- K913247: Solcotrans Orthopaedic Drainage/Reinfusion System, Solco Basle, Inc. (1993) Summary page 1.
- K914119: Davol Orthopaedic Autotransfusion System, Davol, Inc. (1992) Summary page 1.

## Indications for use
The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.

Source page: https://510kreport.com/device/K041525
Methodology: https://510kreport.com/methodology