# JAF: Monitor, Ultrasonic, Nonfetal

- Device class: 2; regulation: 21 CFR 892.1540; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 114 days (middle half 114–114)
- 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)
- 1998: 2
- 2001: 1
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 1
- 2009: 2
- 2011: 1
- 2015: 1
- 2024: 1

## Most-cited predicates
- K942441: Imexdop CT+ (1994), cited by 4
- K973644: Flostat Vascular Lab (1997), cited by 3
- K081429: THD Slide (2008), cited by 3
- K070815: THD (2007), cited by 2
- K904392: Multilab 2000 (1991), cited by 1
- K090009: THD Slide One (2009), cited by 1
- K052067: Doppler Guided Proctoscope, Model 500H (2005), cited by 1
- K973336: Imex Stethodop (1998), cited by 1
- K063600: Vista Avs (2006), cited by 1

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