# K212055: Connected OR Hub with Device and Voice Control

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Dec 16, 2021 after 168 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: 12 generations back to K931783 (1993). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201434: Connected OR Hub with Voice Control, Connected OR Hub with Device Control, Stryker (2020) Summary page 4.
- K192172: Connected OR Hub with Device and Voice Control, Stryker (2019) Summary page 4.
- K181258: ConnectedOR Hub with Device and Voice Control, Stryker (2018) Summary page 4.

## Most influential descendants
- K220108: SDC4K Information Management System with Device and Voice Control Package (2022), 5 descendants of its own
- K222079: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (2022), 4 descendants of its own
- K230886: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (2023), 3 descendants of its own
- K232157: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (2023), 2 descendants of its own
- K241401: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (2024), 1 descendant of its own

## Indications for use
The use of the Connected OR Hub with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

Source page: https://510kreport.com/device/K212055
Methodology: https://510kreport.com/methodology