# K003874: CBC-4K Hematology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Jan 12, 2001 after 28 days
- Product code: JPK (Mixture, Hematology Quality Control)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K052440: Mentor Self-Cath Hydrogel Intermittent Catheter (2005), 3 descendants of its own
- K071496: Icath, Sterilesure (2007), 2 descendants of its own
- K103043: Colorado Catheter Sterilesure - New Name Perfic Cath (2011), 1 descendant of its own
- K161445: PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K003874
Methodology: https://510kreport.com/methodology