510(k) · Cleared
ClearedConnected OR Hub with Device and Voice Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on Dec 16, 2021 as substantially equivalent to K201434 (Stryker, 2020) and 2 other predicates after a 168-day review. Its family tree reaches back 12 generations to 1993. 6 later devices descend from it.
- Decided
- Dec 16, 2021
- Review
- 168 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K931783 (1993). 18 ancestors in all, the oldest K864584 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations between
- 3 generations backK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
- 2 generations backK192172 Connected OR Hub with Device and Voice ControlStryker · 2019
- 1 generation backK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- This deviceK212055 Connected OR Hub with Device and Voice ControlStryker Corporation · 2021
- Descendant · cites it directly · 5 of its ownK220108 SDC4K Information Management System with Device and Voice Control…Stryker Endoscopy · 2022
- Descendant · cites it directly · 4 of its ownK222079 Connected OR Hub with Device and Voice Control, SDC4K Information…Stryker Endoscopy · 2022
- Descendant · 2 generations on · 3 of its ownK230886 Connected OR Hub with Device and Voice Control; SDC4K Information…Stryker Endoscopy · 2023
- Descendant · 3 generations on · 2 of its ownK232157 Connected OR Hub with Device and Voice Control, SDC4K Information…Stryker Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK241401 Connected OR Hub with Device and Voice Control; SDC4K Information…Stryker Endoscopy · 2024
Show all 12 generations
- Root · 12 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 11 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 10 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 9 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 8 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 7 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 6 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 5 generations backK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- 4 generations backK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
- 3 generations backK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
- 2 generations backK192172 Connected OR Hub with Device and Voice ControlStryker · 2019
- 1 generation backK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- This deviceK212055 Connected OR Hub with Device and Voice ControlStryker Corporation · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy · 2022 · cites it directly5descendants
- K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy · 2022 · cites it directly4descendants
- K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…Stryker Endoscopy · 2023 · 2 generations on3descendants
- K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Corporation · 2023 · 3 generations on2descendants
- K241401Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…Stryker Endoscopy · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −11 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −10 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −9 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −8 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −7 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −6 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −5 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| −4 | K160332 | Stryker SDC3 HD Information Management System with Wireless Device Control… | Stryker Endoscopy | 2016 | — |
| −3 | K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | 2018 | — |
| −2 | K192172 | Connected OR Hub with Device and Voice Control | Stryker | 2019 | — |
| −1 | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker | 2020 | — |
| 0 (this device) | K212055 | Connected OR Hub with Device and Voice Control | Stryker Corporation | 2021 | — |
| +1 | K220108 | SDC4K Information Management System with Device and Voice Control Package | Stryker Endoscopy | 2022 | — |
| +1 | K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management… | Stryker Endoscopy | 2022 | — |
| +2 | K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management… | Stryker Endoscopy | 2023 | — |
| +3 | K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management… | Stryker Corporation | 2023 | — |
| +2 | K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management… | Stryker Endoscopy | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device ControlSummary page 4…Product Code: GCJ Subsequent HRX Product Code 510(k) Review General and Plastic Surgery Panel: Predicate Device: | Connected OR Hub with Device and Voice Control | K201434, K192172, K181258 | NOTE: The predicate device has not been subject to a design-related recall. K212055 Page 2 o… | 2020 |
| * | K192172 | Connected OR Hub with Device and Voice ControlSummary page 4…ode: GCJ Subsequent HRX Product Code 510(k) Review General and Plastic Surgery Panel: Predicate Device: | Connected OR Hub with Device and Voice Control | K201434, K192172, K181258 | NOTE: The predicate device has not been subject to a design-related recall. K212055 Page 2 of 5 Devi… | 2019 |
| * | K181258 | ConnectedOR Hub with Device and Voice ControlSummary page 4…Subsequent HRX Product Code 510(k) Review General and Plastic Surgery Panel: Predicate Device: | Connected OR Hub with Device and Voice Control | K201434, K192172, K181258 | NOTE: The predicate device has not been subject to a design-related recall. K212055 Page 2 of 5 Device Descri… | 2018 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K220108 (Stryker Endoscopy, 2022) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K201434.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212055: Connected OR Hub with Device and Voice Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212055
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026