# K040410: Greenlight 300

- Pathway: 510(k) (Traditional)
- Applicant: A C Cossor & Son (Surgical) Limited
- Decided: May 5, 2004 after 77 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790810 (1979). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974080: Critikon Soft Blood Pressure Cuff, Johnson & Johnson Medical, Inc. (1998) Summary page 3.

## Indications for use
The device is intended to be used by medical professionals only for the measurement of systolic and diastolic blood pressure values. The device is intended to be used with blood pressure cuffs supplied for use with the device which are manually attached to a patient and manually inflated, with a manual method for detecting Korotkoff sounds. The device cuffs are available in a range of adult, pediatric and neonate sizes in exactly the same way and substantially equivalent to those cleared for sale in the United States under 510(k) number K974080 making the Accoson greenlight 300 sphygmomanometer device suitable for adult, pediatric and neonate patient groups.

Source page: https://510kreport.com/device/K040410
Methodology: https://510kreport.com/methodology