# K162582: HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare
- Decided: Jun 23, 2017 after 281 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920986 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063546: Insuflow Device, Model 6198, Lexion Medical, LLC (2007) Summary page 4.

## Indications for use
The HumiGard Surgical Humidification System is intended to warm and humidify carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery.

Source page: https://510kreport.com/device/K162582
Methodology: https://510kreport.com/methodology