# K121921: Intuitive Surgical Onsite for DA Vinci Surgical Systems

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Oct 25, 2012 after 115 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: 12 generations back to K930667 (1994). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081207: Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and Onsite, Intuitive Surgical, Inc. (2008) Summary page 1.
- K101581: Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000, Intuitive Surgical, Inc. (2011) Summary page 2.

## Indications for use
OnSite for da Vinci Surgical Systems is an accessory indicated for use by trained Intuitive Surgical Field Service personnel to: (1) obtain system information for the purpose of diagnosing faults, (2) remotely enable/disable features including configuration updates through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.

Source page: https://510kreport.com/device/K121921
Methodology: https://510kreport.com/methodology