# DSB: Plethysmograph, Impedance

- Device class: 2; regulation: 21 CFR 870.2770; FDA's rule: 510(k) required
- FDA decisions: 115
- 510(k) review time 2021–2025: median 242 days (middle half 156–292)
- Recalls: 1 (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: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 1
- 2023: 2
- 2025: 3
- 2026: 1

## Most-cited predicates
- K042113: Zoe Fluid Status Monitor (2004), cited by 5
- K133301: Zoe Fluid Status Monitor (2014), cited by 5
- K830292: Bioelectrical Impedance Analyzer #101 (1983), cited by 4
- K014063: Task Force Monitor 3040 (2002), cited by 4
- K041434: C3 and Lifegard Icg Impedance Cardiography Monitors (2004), cited by 3
- K864889: Omni-Trak (1987), cited by 3
- K011439: Modification to Bioz.Com Hemodynamic Monitor (2001), cited by 3
- K904109: Bio-Impedance Analyzer (1991), cited by 3
- K142503: Imed-Z Fluid Status Monitor (2015), cited by 3
- K041294: Biozdx Hemodynamic Monitor (2004), cited by 3

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