# K071231: Edac Quantifier

- Pathway: 510(k) (Traditional)
- Applicant: Luna Innovations, Inc.
- Decided: May 17, 2007 after 14 days
- Product code: KRL (Detector, Bubble, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4205
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940651 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940651: Sarns Ultrasonic Air Sensor, 3M Health Care, Sarns (1994) Summary page 1.

## Indications for use
The EDACTM QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.

Source page: https://510kreport.com/device/K071231
Methodology: https://510kreport.com/methodology