# K964052: Hemocue Hemotrol

- Pathway: 510(k) (Traditional)
- Applicant: Direct Solutions
- Decided: Nov 6, 1996 after 37 days
- Product code: GGM (Control, Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 2 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) HemoCue Whole Blood Control: named in the summary without a submission number

## Most influential descendants
- K182744: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High (2019), 1 descendant of its own
- K192842: HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High (2019), 0 descendants of its own

## Recalls of this device
- Oct 18, 2018 · Class II · Z-0514-2019: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
- Oct 18, 2018 · Class II · Z-0515-2019: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

Source page: https://510kreport.com/device/K964052
Methodology: https://510kreport.com/methodology