# HIG: Insufflator, Hysteroscopic

- Device class: 2; regulation: 21 CFR 884.1700; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 181 days (middle half 148–214)
- Recalls: 2 (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)
- 2011: 1
- 2012: 1
- 2013: 1
- 2014: 1
- 2017: 1
- 2018: 4
- 2020: 1
- 2021: 1
- 2024: 1
- 2026: 2

## Most-cited predicates
- K112642: Aquilex Fluid Control System H112 (2012), cited by 5
- K022449: Hystereoscopy Pump HM4 (2003), cited by 4
- K936231: The Karl Storz Hamou Endomat (1995), cited by 4
- K933873: Concept Universal Pump System (1994), cited by 4
- K180825: Fluent Fluid Management System (2018), cited by 2
- K011876: Dolphin II Fluid Management System, Model Dol-2 (2002), cited by 2
- K172048: FluidSmart (2017), cited by 2
- K123732: Hysteroscopy Pump HM6 (2013), cited by 2
- K934866: Hys-Surgimat (1995), cited by 1
- K091939: Thermedx Prodigy Fluid Management System, Models P1000, P2000 (2010), cited by 1

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