# LOS: FDA product code

- Device class: —; regulation: 21 CFR —
- FDA decisions: 83
- 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)

## Most-cited predicates
- K921669: Marquette SL Series Transport Remote Acquisition (1993), cited by 7
- K964750: Eagle 4000 Patient Monitor (1997), cited by 6
- K946281: Eclipse 4 Electrocardiograph (1996), cited by 5
- K895520: Pagewriter Xli M1700A & Pagewriter XL M1701A (1990), cited by 4
- K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio (1996), cited by 4
- K991735: Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs (1999), cited by 3
- K083749: CARDIOVIEW32 Review Module (2009), cited by 3
- K991014: Case 8000 Exercise Testing System (1999), cited by 3
- K951130: Cardiosoft/Cardiosys (1996), cited by 3
- K912189: Likepak 11 Cardiac Monit/Lifenet RS100 Rec Station (1992), cited by 3

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