510(k) · Cleared
ClearedSmith & Nephew Control Digital Operating Room System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Nov 23, 2005 as substantially equivalent to K981993 (The Olympus Optical Co., 1998) and 2 other predicates after a 299-day review. Its family tree reaches back 7 generations to 1993. 3 later devices descend from it.
- Decided
- Nov 23, 2005
- Review
- 299 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K931783 (1993). 34 ancestors in all, the oldest K801623 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 6 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 5 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 4 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 3 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 2 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 1 generation backK022393 Merdoc SystemStryker Endoscopy · 2003
- This deviceK050209 Smith & Nephew Control Digital Operating Room SystemSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK070556 Brainsuite NetBrainlab AG · 2007
- Descendant · 2 generations on · 1 of its ownK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK191678 IP ConverterSony Electronics, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −6 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −5 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −4 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −3 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −2 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −1 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| 0 (this device) | K050209 | Smith & Nephew Control Digital Operating Room System | Smith & Nephew, Inc. | 2005 | — |
| +1 | K070556 | Brainsuite Net | Brainlab AG | 2007 | — |
| +2 | K161122 | Sony IP Converter NU-IP40S | Sony Electronics, Inc. | 2016 | — |
| +3 | K191678 | IP Converter | Sony Electronics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K981993 | Olympus Integrated Endosurgery System EndoalphaSummary page 2…Control Digital O.R. SYste Integrated Endosurgery System, cleared in K98 1993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne Tm' System, cleared in K022393. E. Description of… | 1998 |
| * | K990691 | Hermes Operating Room Control CenterSummary page 2…Control Digital O.R. SYste Integrated Endosurgery System, cleared in K98 1993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne Tm' System, cleared in K022393. E. Description of Device The proposed Smith & Nephew Control Digital Operati… | 1999 |
| * | K022393 | Merdoc SystemSummary page 2…= Page 2 === Integrated Endosurgery System, cleared in K98 1993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne Tm' System, cleared in K022393. E. Description of Device The proposed Smith & Nephew Control Digital Operating Room System is a computer based system… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070556 | Brainsuite Net | 2007 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 34 ancestors has a recall.
- Of its descendants, K070556 (Brainlab AG, 2007) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K981993.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and OR. staff.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050209: Smith & Nephew Control Digital Operating Room System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050209
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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