510(k) · Cleared
ClearedStryker Knifelight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · FTD Lamp, Surgical
Cleared on Aug 22, 1996 after a 154-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Aug 22, 1996
- Review
- 154 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK961122 Stryker KnifelightStryker Instruments · 1996
- Descendant · cites it directly · 5 of its ownK041681 Atricure DissectorAtriCure, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK111020 Atricure DissectorAtriCure, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK071180 Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007
- Descendant · 3 generations on · 0 of its ownK232153 AvéliRevelle Aesthetics, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK133425 Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight…Engineered Medical Solutions Co., LLC · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041681Atricure DissectorAtriCure, Inc. · 2004 · cites it directly5descendants
- K111020Atricure DissectorAtriCure, Inc. · 2011 · 2 generations on1descendant
- K071180Scintillant Surgical Light, Model 2644-01-0001Engineered Medical Solutions Co., LLC · 2007 · 2 generations on1descendant
- K232153AvéliRevelle Aesthetics, Inc. · 2023 · 3 generations on0descendants
- K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961122 | Stryker Knifelight | Stryker Instruments | 1996 | — |
| +1 | K041681 | Atricure Dissector | AtriCure, Inc. | 2004 | — |
| +2 | K111020 | Atricure Dissector | AtriCure, Inc. | 2011 | — |
| +2 | K071180 | Scintillant Surgical Light, Model 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007 | — |
| +3 | K232153 | Avéli | Revelle Aesthetics, Inc. | 2023 | — |
| +3 | K133425 | Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip… | Engineered Medical Solutions Co., LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 FTD? 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? (2)
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 |
|---|---|---|---|
| * | — | Biomet product Named without a submission number | |
| * | — | Medtronic product Named without a submission number |
What descends from it? (7)
2 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, K041681 (AtriCure, Inc., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.
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/K961122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961122: Stryker Knifelight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961122
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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