510(k) · Cleared
ClearedQ-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · FSS Light, Surgical, Floor Standing
Cleared on Jun 28, 1996 after a 39-day review. The FDA summary names its predicate without a number. 339 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 39 days
- Class
- Class II
- Product code
- FSS
- Recalls
- None
- Predicates
- 0
339 later devices descend from it, 2 citing it directly.
- This deviceK961971 Q-5000Stryker Endoscopy · 1996
- Descendant · cites it directly · 310 of its ownK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- Descendant · 2 generations on · 300 of its ownK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- Descendant · 2 generations on · 253 of its ownK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- Descendant · 3 generations on · 238 of its ownK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
Showing 5 of 339 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 339 · See all- K973700Hermes Operating Room Control CenterComputer Motion, Inc. · 1998 · cites it directly310descendants
- K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998 · 2 generations on300descendants
- K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999 · 2 generations on253descendants
- K032117Stryker Total Performance (TPS) SystemStryker Instruments · 2003 · 3 generations on238descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| +1 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| +2 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| +2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| +3 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 15 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 15 | 0 |
| 2016 | 18 | 0 |
| 2017 | 8 | 0 |
| 2018 | 15 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 0 |
| 2021 | 15 | 0 |
| 2022 | 28 | 0 |
| 2023 | 19 | 0 |
| 2024 | 30 | 0 |
| 2025 | 35 | 0 |
| 2026 | 20 | 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 FSS? 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 |
|---|---|---|---|
| * | — | Circon-ACMI MV9082 light source Named without a submission number |
What descends from it? (339)
See all 3392 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K973700 (Computer Motion, Inc., 1998) has gone furthest, with 310 descendants of its own.
How does its category compare?
All FSS devicesFSS Light, Surgical, Floor Standing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FSS
Too few FSS 510(k)s in any year since 2007 to give a median.
Recalls per year · FSS
No recall names FSS since 2007.
Adverse event reports per year · FSS
3in 2025
MAUDE reports naming product code FSS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 14 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Endoscopy Q-5000 light source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), and endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consist of the a video camera, a video monitor, a light cable and a scope.
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/K961971 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961971: Q-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961971
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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