# KNG: Monitor, Ultrasonic, Fetal

- Device class: 2; regulation: 21 CFR 884.2660; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 227 days (middle half 201–263)
- 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)
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 3
- 2019: 3
- 2021: 1
- 2022: 2
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K024197: Lifedop Doppler (2003), cited by 7
- K040480: Sonotrax Ultrasonic Pocket Doppler (2004), cited by 5
- K930200: Multi Dopplex II / Fetal Dopplex II (1994), cited by 5
- K991441: Cadence Doppler Ultrasound System (1999), cited by 5
- K080087: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular (2008), cited by 3
- K131457: Fetal Ultrasonic Monitor and Accessories (2014), cited by 2
- K153475: SD5 & SD6 Ultrasonic Tabletop Doppler (2016), cited by 2
- K180419: Ultrasonic Doppler (Model YM-2T8) (2018), cited by 2
- K140579: Ultrasonic Pocket Doppler (2015), cited by 2
- K092997: Ultrasonic Tabletop Doppler, Models SD5 and SD6 (2009), cited by 2

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