510(k) · Cleared
ClearedSmith+Nephew INTELLIO Tablet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith+Nephew · ODA Endoscopic Central Control Unit
Cleared on Sep 6, 2022 as substantially equivalent to K203566 (Smith & Nephew, 2021) after a 67-day review. Its family tree reaches back 10 generations to 1983.
- Decided
- Sep 6, 2022
- Review
- 67 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K833587 (1983). 39 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 6 generations between
- 3 generations backK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- 2 generations backK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- 1 generation backK203566 Tablet ApplicationSmith & Nephew · 2021
- This deviceK221929 Smith+Nephew INTELLIO TabletSmith+Nephew · 2022
Show all 10 generations
- Root · 10 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 9 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 8 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 7 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 6 generations backK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- 5 generations backK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- 4 generations backK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- 3 generations backK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- 2 generations backK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- 1 generation backK203566 Tablet ApplicationSmith & Nephew · 2021
- This deviceK221929 Smith+Nephew INTELLIO TabletSmith+Nephew · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −9 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −8 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −7 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −6 | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| −5 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| −4 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| −3 | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| −2 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| −1 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
| 0 (this device) | K221929 | Smith+Nephew INTELLIO Tablet | Smith+Nephew | 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 ODA? 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 ODA device
- #1 K203566 Tablet Applicationscore 6.7 · 9 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 |
|---|---|---|---|
| * | K203566 | Tablet ApplicationSummary page 4…fundamental scientific technology to the following legally marketed device currently in commercial distribution: Smith+Nephew Tablet Application cleared in K203566. E. Description of Device The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that i… | 2021 |
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 3.0 years on median.
- 4 of the 39 ancestors have a recall of any class.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ODA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · ODA
Too few ODA 510(k)s in any year since 2007 to give a median.
Recalls per year · ODA
No recall names ODA since 2007.
Adverse event reports per year · ODA
3in 2025
MAUDE reports naming product code ODA, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera/camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221929: Smith+Nephew INTELLIO Tablet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221929
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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