# K003792: Stryker Heated Insufflator Tube Set

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Feb 21, 2001 after 75 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 1 cites it directly.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own
- K143404: SurgiQuest AirSeal iFS System (2015), 27 descendants of its own

## Recalls of this device
- Mar 7, 2019 · Class II · Z-1728-2019: The heated tube sets were consistently leaking and detaching from the cassette.

Source page: https://510kreport.com/device/K003792
Methodology: https://510kreport.com/methodology