# K022167: Pall Doner Pre-Evacuated Post-Operative Autologous Blood Reinfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Pall Corp.
- Decided: Mar 7, 2003 after 247 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Zimmer Hemovac: named in the summary without a submission number
- (no number) Gish Biomedical, Inc.’s Orthofusor Wound Drainage/Autotransfusion System: named in the summary without a submission number
- (no number) Richards’ Solocotrans: named in the summary without a submission number
- (no number) Stryker Surgical’s CBC-ConstaVac: named in the summary without a submission number

## Indications for use
Pall Donor Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgery patient’s wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.

Source page: https://510kreport.com/device/K022167
Methodology: https://510kreport.com/methodology