510(k) · Cleared
ClearedKarl Storz Optical Mediastinoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EWY Mediastinoscope, Surgical
Cleared on Nov 3, 1995 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 3, 1995
- Review
- 9 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK954910 Karl Storz Optical MediastinoscopeKARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK971166 Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceRichard Wolf Medical Instruments Corp. · 1997
- Descendant · 2 generations on · 2 of its ownK141622 Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK213194 HD MediastinoscopeKarl Storz Endoscopy America, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK160171 Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK260003 KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K971166Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceRichard Wolf Medical Instruments Corp. · 1997 · cites it directly4descendants
- K141622Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015 · 2 generations on2descendants
- K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc. · 2022 · cites it directly1descendant
- K160171Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016 · 3 generations on1descendant
- K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954910 | Karl Storz Optical Mediastinoscope | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K971166 | Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +2 | K141622 | Illuminated Mediastinoscope | Aegis Surgical, Ltd. | 2015 | — |
| +1 | K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022 | — |
| +3 | K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016 | — |
| +1 | K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWY? 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 EWY device
- #1 K260003 KARL STORZ Mediastinoscopes and Instrumentsscore 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
4 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, K971166 (Richard Wolf Medical Instruments Corp., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EWY devicesEWY Mediastinoscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWY
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · EWY
Too few EWY 510(k)s in any year since 2007 to give a median.
Recalls per year · EWY
No recall names EWY since 2007.
Adverse event reports per year · EWY
105in 2025
MAUDE reports naming product code EWY, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 12 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 97 |
| 2024 | 0 | — | 0 | 99 |
| 2025 | 0 | — | 0 | 105 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K954910 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954910: Karl Storz Optical Mediastinoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954910
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026