510(k) · Cleared
ClearedSmith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith and Nephew, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Oct 20, 2022 as substantially equivalent to K191177 (Smith and Nephew, Inc., 2019) after a 127-day review. Its family tree reaches back 8 generations to 1983.
- Decided
- Oct 20, 2022
- Review
- 127 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K833587 (1983). 37 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 8 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 7 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 6 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 5 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 4 generations backK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- 3 generations backK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- 2 generations backK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- 1 generation backK191177 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit -…Smith and Nephew, Inc. · 2019
- This deviceK221740 Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled…Smith and Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −7 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −6 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −5 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −4 | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| −3 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| −2 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| −1 | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi… | Smith and Nephew, Inc. | 2019 | — |
| 0 (this device) | K221740 | Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447)… | Smith and Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K191177 | LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Summary page 4…M The INTELLIO 4K CCU is substantially equivalent to the Smith and Nephew LENS 4K System Camera Control Unit, cleared by the FDA under the Premarket Notification K191177. The INTELLIO 4K CCU has an updated Graphical User Interface (GUI) and can be operated by an optional accessory, the INTE… | 2019 |
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 39 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 4 of the 37 ancestors have a recall of any class.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.
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/K221740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221740: Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith & Nephew Intellio 4K Camera Control Unit, Non-Network Enabled (72205448).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221740
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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