# K982707: EC6 Plethysmograph

- Pathway: 510(k) (Special)
- Applicant: D. E. Hokanson, Inc.
- Decided: Aug 26, 1998 after 23 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093192: Flochec Photo Plethysmographic Device (2010), 1 descendant of its own
- K143094: QuantaFlo (2015), 0 descendants of its own

## Indications for use
The EC6 is two plethysmographs in one. A mercury strain gauge plethysmograph accgrately mea§ures_vblume changes in limbs or digits. It is used, in conjunction with blood pressure cuffs, to measure blood pressure, pulse vo}ume waveforms and amplitudes, and blood flow into or out of limbs and digits. The instrument also contains an infrared phgto plethysmograph which, although not calibrated, is a sensitive pulse detector which is used to evaluate pulse wave shapes gnd measure blood pressure in the extremities in conjunction with blood pressure cuffs.

Source page: https://510kreport.com/device/K982707
Methodology: https://510kreport.com/methodology