# K970714: Stryker Constavac Blood Conservation System II (Cbcii)

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Dec 16, 1997 after 292 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 4 (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. The FDA summary names its predicate without a number.
- (no number) Baxter V. Mueller products: named in the summary without a submission number
- (no number) Zimmer products: named in the summary without a submission number

## Recalls of this device
- Mar 26, 2015 · Class II · Z-1572-2015: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- Mar 26, 2015 · Class II · Z-1571-2015: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- Mar 26, 2015 · Class II · Z-1573-2015: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- Mar 26, 2015 · Class II · Z-1570-2015: Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

## Indications for use
The Stryker ConstaVac Blood Conservation System I (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal method for wound drainage collected in the CBCII reservoir.

Source page: https://510kreport.com/device/K970714
Methodology: https://510kreport.com/methodology