# HIF: Insufflator, Laparoscopic

- Device class: 2; regulation: 21 CFR 884.1730; FDA's rule: 510(k) required
- FDA decisions: 179
- 510(k) review time 2021–2025: median 155 days (middle half 123–229)
- Recalls: 17 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 3
- 2019: 2
- 2020: 4
- 2021: 1
- 2022: 1
- 2023: 7
- 2024: 4
- 2025: 3
- 2026: 3

## Most-cited predicates
- K063367: 45L Core Insufflator, Model F114 (2007), cited by 7
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), cited by 5
- K063546: Insuflow Device, Model 6198 (2007), cited by 5
- K090456: Insuflow (2009), cited by 4
- K030837: 40 L High Flow Insufflator F108 (2004), cited by 4
- K000180: Transanal Endoscopic Microsurgery (Tem) Combination System and Instrument Set, Instrument Set for the Transanal Endoscop (2001), cited by 3
- K153513: Insufflator 50L FM134 (2016), cited by 3
- K122180: High Flow Insufflantion Unit (2012), cited by 3
- K002328: Sios-Interface for Auto Light Projector, Sios-Interface for 3 CCD Endocam, Sios-Interface for Laparo CO2 Insufflator (2001), cited by 3
- K052125: Carbonaid Gas Diffuser (2006), cited by 3

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