510(k) · Cleared
ClearedConnectedOR Hub with Device and Voice Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 5, 2018 as substantially equivalent to K160332 (Stryker Endoscopy, 2016) after a 178-day review. Its family tree reaches back 9 generations to 1993. 10 later devices descend from it.
- Decided
- Nov 5, 2018
- Review
- 178 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931783 (1993). 12 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations between
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- 1 generation backK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
- This deviceK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
- Descendant · cites it directly · 9 of its ownK192172 Connected OR Hub with Device and Voice ControlStryker · 2019
- Descendant · cites it directly · 8 of its ownK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- Descendant · cites it directly · 6 of its ownK212055 Connected OR Hub with Device and Voice ControlStryker Corporation · 2021
- Descendant · 2 generations on · 5 of its ownK220108 SDC4K Information Management System with Device and Voice Control…Stryker Endoscopy · 2022
- Descendant · 2 generations on · 4 of its ownK222079 Connected OR Hub with Device and Voice Control, SDC4K Information…Stryker Endoscopy · 2022
Show all 9 generations
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 2 generations backK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- 1 generation backK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
- This deviceK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K192172Connected OR Hub with Device and Voice ControlStryker · 2019 · cites it directly9descendants
- K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlStryker · 2020 · cites it directly8descendants
- K212055Connected OR Hub with Device and Voice ControlStryker Corporation · 2021 · cites it directly6descendants
- K220108SDC4K Information Management System with Device and Voice Control PackageStryker Endoscopy · 2022 · 2 generations on5descendants
- K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with…Stryker Endoscopy · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −8 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −7 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −6 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −5 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −4 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −3 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −2 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| −1 | K160332 | Stryker SDC3 HD Information Management System with Wireless Device Control… | Stryker Endoscopy | 2016 | — |
| 0 (this device) | K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | 2018 | — |
| +1 | 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 | — |
| +1 | K212055 | Connected OR Hub with Device and Voice Control | Stryker Corporation | 2021 | — |
| +2 | K220108 | SDC4K Information Management System with Device and Voice Control Package | Stryker Endoscopy | 2022 | — |
| +2 | K222079 | Connected OR Hub with Device and Voice Control, SDC4K Information Management… | Stryker Endoscopy | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K160332 | Stryker SDC3 HD Information Management System with Wireless Device Control CapabilitySummary page 5…ice is the latest iteration of the Stryker SDC3 HD Information Management System with wireless device control (hereafter referred to as “predicate device”, cleared under K160332). The device and voice control features of the proposed device are identical to the predicate device. The operating room document… | 2016 |
What descends from it? (10)
3 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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K192172 (Stryker, 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K160332.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 ConnectedOR Hub is indicated for use with compatible endoscopic and general surgery devices. The ConnectedOR Hub can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic…
Read the full statement (142 words)
The ConnectedOR Hub is indicated for use with compatible endoscopic and general surgery devices. The ConnectedOR Hub can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. ConnectedOR Hub users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181258: ConnectedOR Hub with Device and Voice Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181258
Report an extraction error
Are you the manufacturer?
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