# MLD: Monitor, St Segment With Alarm

- Device class: 2; regulation: 21 CFR 870.1025; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 2 (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)
- 1995: 1
- 1996: 2
- 1997: 2
- 1998: 2
- 1999: 1
- 2000: 1
- 2001: 1
- 2002: 1
- 2008: 1
- 2010: 1

## Most-cited predicates
- K920429: Modified Model M1403A Telemetry Monitoring System (1993), cited by 3
- K960272: Eagle 3000/3100 Patient Monitor (1996), cited by 2
- K022740: Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU02 & L-CICU02A Software (2002), cited by 2
- K972121: Acuity Central Station (1997), cited by 2
- K992323: Datex-Ohmeda Cardiocap 5, F-MX, F-MXG and Accessories (1999), cited by 2
- K982104: Escort-Link Central Station Monitor Model 20500 (1998), cited by 2
- K080461: Star ST and Arrhythmia Software, Release J.0 (2008), cited by 2
- K935020: Omni-Trac Modification (1995), cited by 1
- K002105: Siemens Infinity SC 6002XL Enhanced with ST Segment Analysis (2000), cited by 1
- K960934: HP M1205A Omnicare Component Monitor System Model 24 (1996), cited by 1

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