510(k) · Cleared
ClearedOptical Mediastinoscope with Plug-in Connection/Ocular Eyepiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · EWY Mediastinoscope, Surgical
Cleared on Aug 27, 1997 as substantially equivalent to K954910 (KARL STORZ Endoscopy-America, Inc., 1995) after a 149-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Aug 27, 1997
- Review
- 149 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954910 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954910 Karl Storz Optical MediastinoscopeKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK971166 Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceRichard Wolf Medical Instruments Corp. · 1997
- Descendant · cites it directly · 2 of its ownK141622 Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK170757 Aegis Transit SystemBoston-Biomedical Associates · 2017
Most influential descendants
Showing 4 of 4 · See all- K141622Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015 · cites it directly2descendants
- K160171Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016 · 2 generations on1descendant
- K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026 · cites it directly0descendants
- K170757Aegis Transit SystemBoston-Biomedical Associates · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954910 | Karl Storz Optical Mediastinoscope | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K971166 | Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +1 | K141622 | Illuminated Mediastinoscope | Aegis Surgical, Ltd. | 2015 | — |
| +2 | K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016 | — |
| +1 | K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026 | — |
| +2 | K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K954910 | Karl Storz Optical MediastinoscopeSummary page 1…tial equivalence is claimed: 310(k) Numbcer Tradc or proprictary or model name Manufacturer | pre-enact. 1 Fiber Light Mcdiastinoscope 8960.01/ .03 I Richard WolfM.1.C. 2K 9549 10 |2 Optical Mediastinoscope 10970BV 2 Karl Storz 3 3 Mediastinoscope "CARLENS™ 10970A/B and 3 Karl Storz operating instruments 1… | 1995 |
| * | — | Fiber Light Mediastinoscope 8960.01/.03 Named without a submission number | |
| * | — | Mediastinoscope “CARLENS™” 10970A/B and operating instruments Named without a submission number |
What descends from it? (4)
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?
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 | — |
What is it indicated for?
The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum. Mediastinoscopy is carried out: - In order to evaluate the operability of patients suffering from bronchial carcinoma which have already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies. - For diagnostic clarification of primary and secondary…
Read the full statement (243 words)
The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum.
Mediastinoscopy is carried out:
- In order to evaluate the operability of patients suffering from bronchial carcinoma which have already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies.
- For diagnostic clarification of primary and secondary diseases of the mediastinum, when other examination methods have been unable to provide the nature, and in particular the histological character of the disturbance.
- For the removal of nodes and tumors.
- For the diagnosis and removal of lymphatic nodes.
Various auxiliary instruments are used in mediastinoscopy:
The smoke evacuation tube is used to evacuate smoke during HF or laser applications.
The telescope rinsing tube (optic irrigation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid.
The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for cyto/histological purposes.
The tumor grasping forceps are used for grasping and manipulating tissue.
The micro grasping forceps with HF are used for coagulating small vessels and grasping.
The HF coagulation suction devices are used for suction and for coagulation while holding tissue ‘out of the way’ during endoscopic operations of the larynx in connection with CO₂ lasers or in mediastinoscopy.
The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for coagulation of small lesions.
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/K971166 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971166
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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