# K922770: Unistat Bilirubinometer Models 10310 and 10311

- Pathway: 510(k) (Traditional)
- Applicant: Leica, Inc.
- Decided: Aug 18, 1992 after 70 days
- Product code: MQM (Bilirubin (Total And Unbound) In The Neonate Test System)
- Device class: 1
- Regulation: 21 CFR 862.1113
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- K991417: Abl 735 Analyzer (1999), 16 descendants of its own
- K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to (2010), 12 descendants of its own
- K112995: Gem Premier 4000 (2012), 11 descendants of its own
- K133407: Gem Premier 4000 (2014), 10 descendants of its own
- K173403: GEM Premier 5000 (2017), 2 descendants of its own

Source page: https://510kreport.com/device/K922770
Methodology: https://510kreport.com/methodology