510(k) · Cleared
ClearedSmith & Nephew Tablet Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew · QGY Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
Cleared on May 21, 2019 as substantially equivalent to K153606 (Smith & Nephew, 2016) after a 95-day review. Its family tree reaches back 7 generations to 1983. 3 later devices descend from it.
- Decided
- May 21, 2019
- Review
- 95 days
- Class
- Class II
- Product code
- QGY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K833587 (1983). 36 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 6 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 5 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 4 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 3 generations backK072675 Smith & Nephew ArthroscopeSmith & Nephew, Inc. · 2007
- 2 generations backK101734 Visionscope High Definition Endoscopy Camera System with; Camera…Visionscope Technologies, LLC · 2010
- 1 generation backK153606 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS…Smith & Nephew · 2016
- This deviceK190367 Smith & Nephew Tablet ApplicationSmith & Nephew · 2019
- Descendant · cites it directly · 2 of its ownK192876 INTELLIO Tablet ApplicationSmith & Nephew · 2020
- Descendant · 2 generations on · 1 of its ownK203566 Tablet ApplicationSmith & Nephew · 2021
- Descendant · 3 generations on · 0 of its ownK221929 Smith+Nephew INTELLIO TabletSmith+Nephew · 2022
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 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −6 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −5 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −4 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −3 | K072675 | Smith & Nephew Arthroscope | Smith & Nephew, Inc. | 2007 | — |
| −2 | K101734 | Visionscope High Definition Endoscopy Camera System with; Camera Control Unit… | Visionscope Technologies, LLC | 2010 | — |
| −1 | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head… | Smith & Nephew | 2016 | — |
| 0 (this device) | K190367 | Smith & Nephew Tablet Application | Smith & Nephew | 2019 | — |
| +1 | K192876 | INTELLIO Tablet Application | Smith & Nephew | 2020 | — |
| +2 | K203566 | Tablet Application | Smith & Nephew | 2021 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 QGY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K153606 | LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Summary page 4…se and fundamental scientific technology to the following legally marketed device in commercial distribution: Smith & Nephew LENS Integrated System APP cleared in K153606 Endoscopy T 978-749-1000 Smith & Nephew, Inc. F 978-749-1443 150 Minutem… | 2016 |
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 |
|---|---|---|---|
| K192876 | INTELLIO Tablet Application | 2020 | 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 36 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 4 of the 36 ancestors have a recall of any class.
- Of its descendants, K192876 (Smith & Nephew, 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K153606.
How does its category compare?
All QGY devicesQGY Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QGY
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QGY
Too few QGY 510(k)s in any year since 2007 to give a median.
Recalls per year · QGY
No recall names QGY since 2007.
Adverse event reports per year · QGY
No MAUDE report names QGY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Smith & Nephew Tablet Application is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices including camera/camera control unit and patient information system.
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/K190367 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190367: Smith & Nephew Tablet Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190367
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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