# HGM: System, Monitoring, Perinatal

- Device class: 2; regulation: 21 CFR 884.2740; FDA's rule: 510(k) required
- FDA decisions: 215
- 510(k) review time 2021–2025: median 227 days (middle half 181–267)
- Recalls: 24 (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)
- 2015: 5
- 2016: 1
- 2017: 3
- 2018: 3
- 2020: 1
- 2022: 1
- 2023: 2
- 2024: 1
- 2025: 4
- 2026: 2

## Most-cited predicates
- K900480: M1350A Fetal Monitor (Intrapartum) (1990), cited by 7
- K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A (2003), cited by 6
- K954351: Series 50XM (1996), cited by 6
- K970456: Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving System (1997), cited by 5
- K934959: Model 118 Fetal/Maternal Monitor (1994), cited by 4
- K891595: Model 116 Fetal Monitor (1989), cited by 4
- K852608: Spectra 400 Extended Surveillance & Alert System (1985), cited by 4
- K960109: Quantitative Sentinel System (1996), cited by 4
- K052795: Philips Avalon Fetal Monitor, Models FM20 and FM30 (2005), cited by 3
- K993008: Quantitative Sentinel System (1999), cited by 3

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