# K010598: Synovialscopics, Synovial Fluid Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Mar 23, 2001 after 23 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K041240: Semen Analysis Quality Control, Assayed and Unassayed (2004), 0 descendants of its own

## Recalls of this device
- Jun 1, 2007 · Not classified · Z-0516-2009: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

Source page: https://510kreport.com/device/K010598
Methodology: https://510kreport.com/methodology