510(k) · Cleared
ClearedIlluminated Mediastinoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aegis Surgical, Ltd. · EWY Mediastinoscope, Surgical
Cleared on Jan 9, 2015 as substantially equivalent to K971166 (Richard Wolf Medical Instruments Corp., 1997) after a 206-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 9, 2015
- Review
- 206 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954910 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954910 Karl Storz Optical MediastinoscopeKARL STORZ Endoscopy-America, Inc. · 1995
- 1 generation backK971166 Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceRichard Wolf Medical Instruments Corp. · 1997
- This deviceK141622 Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK160171 Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK170757 Aegis Transit SystemBoston-Biomedical Associates · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K141622 | Illuminated Mediastinoscope | Aegis Surgical, Ltd. | 2015 | — |
| +1 | K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016 | — |
| +1 | K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K971166 | Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceSummary page 4…CLASS MANUFACTURER 510(K) DEVICE NAME/DESCRIPTION NUMBER II Richard Wolf K971166 Richard Wolf Optical Mediastinoscope 4. Device D… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K160171 (Aegis Surgical, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K971166.
How does its category compare?
All EWY devicesEWY Mediastinoscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Illuminated Mediastinal Access Port is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures.
The Illuminated Mediastinal Access Port is specifically indicated for use in the anterior, superior and middle mediastinum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141622: Illuminated Mediastinoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141622
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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