# K222240: Explorer Air® II

- Pathway: 510(k) (Traditional)
- Applicant: Surgvision GmbH
- Decided: Feb 28, 2023 after 217 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K930667 (1994). 104 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214097: Explorer Air II, Surgvision GmbH (2022) Summary page 4.
- K210265: VS3 Iridium Sytem, Visionsense, Ltd. (2021) Summary page 4.

## Most influential descendants
- K234090: EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (2024), 0 descendants of its own

## Indications for use
Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older. Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Source page: https://510kreport.com/device/K222240
Methodology: https://510kreport.com/methodology