# K143404: SurgiQuest AirSeal iFS System

- Pathway: 510(k) (Traditional)
- Applicant: Surgiquest, Inc.
- Decided: Mar 20, 2015 after 112 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K964171 (1997). 29 ancestors in all.
27 later devices descend from it; 2 cite it directly.
3 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000, Surgiquest, Inc. (2011) Summary page 4.
- K122180: High Flow Insufflantion Unit, Olympus Medical Systems Corporation (2012) Summary page 4.

## Most influential descendants
- K170784: Pneumoclear (2017), 17 descendants of its own
- K201361: Pneumoclear (2020), 14 descendants of its own
- K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (2024), 11 descendants of its own
- K172516: SurgiQuest AIRSEAL iFS System (2018), 8 descendants of its own
- K193520: EVA 15 Insufflator (2020), 5 descendants of its own

## Recalls of this device
- May 14, 2026 · Class II · Z-2472-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2467-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2469-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2465-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2471-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2474-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2473-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2470-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2466-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2464-2026: Potential for overpressure alerts.
- May 14, 2026 · Class II · Z-2468-2026: Potential for overpressure alerts.

## Indications for use
The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

Source page: https://510kreport.com/device/K143404
Methodology: https://510kreport.com/methodology