# LYR: Helicobacter Pylori

- Device class: 1; regulation: 21 CFR 866.3110; FDA's rule: 510(k) required
- FDA decisions: 91
- 510(k) review time 2021–2025: median 91 days (middle half 90–93)
- Recalls: 11 (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)
- 2003: 5
- 2004: 1
- 2006: 3
- 2012: 2
- 2015: 2
- 2016: 2
- 2018: 4
- 2019: 1
- 2020: 1
- 2023: 2

## Most-cited predicates
- K053335: Premier Platinum Hpsa Plus, Models 601396, 601480 (2006), cited by 3
- K952220: Meretek Breath Test for H.Pylori Collection Kit (1996), cited by 3
- K182559: PREMIER Platinum HpSA PLUS (2018), cited by 3
- K032222: Immunocardstat Hpsa (2003), cited by 2
- K983255: Modification to: Premier Platinum Hpsa (1998), cited by 2
- K934863: Flexsure HP (1994), cited by 2
- K953632: Serim Pyloritek Test Kit (1995), cited by 2
- K000463: Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg (2000), cited by 2
- K944159: HM-Cap Eia Kit (1995), cited by 1
- K980076: Premier Platinum Hpsa (1998), cited by 1

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