# K193361: ProCell Surgical Sponge-Blood Recovery Unit

- Pathway: 510(k) (Traditional)
- Applicant: Procell Surgical, Inc.
- Decided: Jun 1, 2020 after 180 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: 6 generations back to K801043 (1980). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140205: Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System, Teleflexmedical, Inc. (2014) Summary page 4.

## Indications for use
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT. ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCell™ prior to reinfusion into the patient (autologous blood transfusion). Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.

Source page: https://510kreport.com/device/K193361
Methodology: https://510kreport.com/methodology