# K023707: A16 Blood Flow Measurement System

- Pathway: 510(k) (Special)
- Applicant: D. E. Hokanson, Inc.
- Decided: Feb 12, 2003 after 100 days
- Product code: JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic)
- Device class: 2
- Regulation: 21 CFR 870.2780
- 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) EC6 Plethysmograph: named in the summary without a submission number
- (no number) E20: named in the summary without a submission number

## Indications for use
The intended use of the A16 is the measurement of blood flow by means of venous occlusion plethysmography. This is the same usage as one of the uses of our EC6 Plethysmograph and it has not changed.

Source page: https://510kreport.com/device/K023707
Methodology: https://510kreport.com/methodology