# K234090: EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

- Pathway: 510(k) (Traditional)
- Applicant: Surgvision GmbH
- Decided: Mar 20, 2024 after 89 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: 21 generations back to K930667 (1994). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222240: Explorer Air® II, Surgvision GmbH (2023) Summary page 4.

## 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/K234090
Methodology: https://510kreport.com/methodology