# MQM: Bilirubin (Total And Unbound) In The Neonate Test System

- Device class: 1; regulation: 21 CFR 862.1113; FDA's rule: 510(k) required
- FDA decisions: 17
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2000: 1
- 2001: 2
- 2003: 1
- 2004: 1
- 2005: 1
- 2008: 1
- 2011: 1
- 2014: 2
- 2017: 1

## Most-cited predicates
- K922770: Unistat Bilirubinometer Models 10310 and 10311 (1992), cited by 3
- K972309: JM-102 Jaundice Meter (1998), cited by 1
- K132691: ABL90 Flex (2014), cited by 1
- K042522: Jaundice Meter, Model JM 103 (2005), cited by 1
- K964590: Colormate Iii (1997), cited by 1
- K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265 (2008), cited by 1
- K983071: Bilichek Non-Invasive Bilirubin Analyzer (1999), cited by 1
- K021622: Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103 (2003), cited by 1

Source page: https://510kreport.com/product-code/MQM
Data by year (CSV): https://510kreport.com/product-code/MQM.csv