# KNA: Instrument, Manual, Specialized Obstetric-Gynecologic

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 58
- 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)
- 1997: 2
- 1998: 3
- 1999: 2
- 2000: 1
- 2002: 2
- 2006: 2
- 2009: 1
- 2010: 1
- 2011: 1
- 2014: 1

## Most-cited predicates
- K013597: Tamponade Uterine Balloon Catheter Set (2002), cited by 4
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500 (2006), cited by 3
- K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 (2006), cited by 2
- K842231: Ackrad Hysterosalpingography Set (1984), cited by 2
- K861385: Milex Bartholin Gland Catheter (1986), cited by 1
- K880497: Word Bartholin Gland Catheter Code: 1005 (1988), cited by 1
- K982464: SCC-23 Safety Clamp and Cutter (1998), cited by 1

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