# K791844: Critiflo & Critiflo Dome

- Pathway: 510(k) (Traditional)
- Applicant: Gould, Inc.
- Decided: Oct 2, 1979 after 13 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: 7 (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
- Jul 1, 2005 · Not classified · Z-0069-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0073-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0074-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0075-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0070-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0071-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
- Jul 1, 2005 · Not classified · Z-0072-06: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.

Source page: https://510kreport.com/device/K791844
Methodology: https://510kreport.com/methodology