# HDB: Extractor, Vacuum, Fetal

- Device class: 2; regulation: 21 CFR 884.4340; FDA's rule: 510(k) required
- FDA decisions: 30
- 510(k) review time 2021–2025: median 250 days (middle half 250–250)
- Recalls: 5 (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)
- 1994: 1
- 1995: 2
- 1996: 2
- 1997: 2
- 1998: 3
- 2001: 1
- 2002: 2
- 2003: 1
- 2005: 2
- 2025: 1

## Most-cited predicates
- K890307: Mityvac M Style Vacuum Extractor, Disposable (1989), cited by 3
- K011532: Mityvac (2001), cited by 2
- K895700: Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor (1990), cited by 2
- K981260: Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M (1998), cited by 2
- K970170: Swift Delivery Product #002-Vac EX Cup W/Vac Rel Valve (1997), cited by 2
- K934011: Mityvac (R) Obstetric Vac Deliv Kit W/Univ Vac Release (1994), cited by 1
- K942725: Cmi Velvet Touch Vacuum Extractor (1995), cited by 1
- K841492: AB Vacuum Extractor Silc-Cup (1984), cited by 1
- K881967: Cmi Vacuum Pump #001C - Vacuum Pump (Non-Electri.) (1988), cited by 1
- K943938: Mityvac Super M Style Vacum Extractor, Disposable (1995), cited by 1

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