# K212101: da Vinci SP Firefly Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Nov 23, 2021 after 140 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- 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: 16 generations back to K930667 (1994). 82 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210918: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System, Intuitive Surgical, Inc. (2021) Summary page 4.

## Most influential descendants
- K250786: SP Endoscope, 0° (430600) (2025), 1 descendant of its own
- K252350: da Vinci SP Firefly Imaging System (2025), 0 descendants of its own

## Indications for use
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

Source page: https://510kreport.com/device/K212101
Methodology: https://510kreport.com/methodology