# K893519: Twin-Fusor/Uni-Fusor Blood & Fluid Infusion Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Statlabs, Inc.
- Decided: Aug 15, 1989 after 99 days
- Product code: KZB (Automated Colony Counter)
- Device class: 1
- Regulation: 21 CFR 866.2170
- Recalls of this device: 11 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 20, 2008 · Not classified · Z-0461-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0465-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0462-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0463-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0466-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0464-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0469-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0470-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0471-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0467-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.
- Sep 20, 2008 · Not classified · Z-0468-2009: Leaks: Infusion Cuffs may exhibit air leakage at the union of the tube and bag, and not maintain pressure. For further information, please contact the firm at 203-488-6056.

Source page: https://510kreport.com/device/K893519
Methodology: https://510kreport.com/methodology