# K260710: FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)

- Pathway: 510(k) (Traditional)
- Applicant: FloShield, Inc.
- Decided: Jun 11, 2026 after 99 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K904871 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045, Minimally Invasive Devices, LLC (2008) Summary page 5.

## Indications for use
The Air Only FloShield System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging of the lens of a laparoscope and divert surgical debris during minimally- invasive surgery while maintaining visualization of the surgical site.

Source page: https://510kreport.com/device/K260710
Methodology: https://510kreport.com/methodology