# K992785: Ibc Floguard, Model 6050

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Jan 14, 2000 after 148 days
- Product code: MJJ (Cpb Check Valve, Retrograde Flow, In-Line)
- Device class: 2
- Regulation: 21 CFR 870.4400
- 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) Quest RetroGuard: named in the summary without a submission number

## Indications for use
The IBC FioGard is indicated for use for the prevention of retrograde flow when used with centrifugal pumps during cardiopulmonary bypass surgery (up to six hours).

Source page: https://510kreport.com/device/K992785
Methodology: https://510kreport.com/methodology