# K963703: Accuflo Monitoring System (1800)/ Accuflo Probe (8000)

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Apr 8, 1998 after 569 days
- Product code: DPT (Probe, Blood-Flow, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2120
- Recalls of this device: 1 (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) Biomedicus Bioprobe Electromagnetic Flow System: named in the summary without a submission number

## Recalls of this device
- Apr 22, 2005 · Not classified · Z-1223-06: Complaints received regarding the device's failure to zero out.

## Indications for use
The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.

Source page: https://510kreport.com/device/K963703
Methodology: https://510kreport.com/methodology