# K940430: Sedratrol

- Pathway: 510(k) (Traditional)
- Applicant: Medical Specialties Intl., Inc.
- Decided: Feb 6, 1995 after 371 days
- Product code: GJR (Control, Red-Cell)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972172: Esr Control-M Hematology Erythrocyte Sedimentation (1997), 1 descendant of its own
- K991876: Sedrite Plus Erythrocyte Sedimentation Rate (1999), 0 descendants of its own
- K972170: Esr Control-HC Hematology Erythrocyte Sedimentation (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K940430
Methodology: https://510kreport.com/methodology