510(k) · Cleared
ClearedSDC3 HD Information Management System with Wireless Device Control Capability
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 Mar 18, 2021 as substantially equivalent to K160332 (Stryker Endoscopy, 2016) after a 20-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Mar 18, 2021
- Review
- 20 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. No later device cites it as a predicate yet.
- 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 deviceK210584 SDC3 HD Information Management System with Wireless Device Control…Stryker · 2021
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 deviceK210584 SDC3 HD Information Management System with Wireless Device Control…Stryker · 2021
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) | K210584 | SDC3 HD Information Management System with Wireless Device Control Capability | Stryker | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 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 4…Class II Product Code GCJ; HRX Predicate Device: Predicate Device SDC3 HD Information Management System K160332 with Wireless Device Control Capability NOTE: The predicate device has not been subject to a d… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 12 ancestors has a recall.
- 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. 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 intended use of the SDC3 HD Information Management System with Wireless Device Control Capability 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 SDC3 with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the…
Read the full statement (107 words)
The intended use of the SDC3 HD Information Management System with Wireless Device Control Capability 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 SDC3 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/K210584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210584: SDC3 HD Information Management System with Wireless Device Control Capability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210584
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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