510(k) · Cleared
ClearedAegis Transit System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston-Biomedical Associates · EWY Mediastinoscope, Surgical
Cleared on Jul 14, 2017 as substantially equivalent to K141622 (Aegis Surgical, Ltd., 2015) and 1 other predicate after a 123-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jul 14, 2017
- Review
- 123 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954910 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK954910 Karl Storz Optical MediastinoscopeKARL STORZ Endoscopy-America, Inc. · 1995
- 3 generations backK971166 Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceRichard Wolf Medical Instruments Corp. · 1997
- 2 generations backK141622 Illuminated MediastinoscopeAegis Surgical, Ltd. · 2015
- 1 generation backK160171 Illuminated Mediastinal Access PortAegis Surgical, Ltd. · 2016
- This deviceK170757 Aegis Transit SystemBoston-Biomedical Associates · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954910 | Karl Storz Optical Mediastinoscope | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −3 | K971166 | Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece | Richard Wolf Medical Instruments Corp. | 1997 | — |
| −2 | K141622 | Illuminated Mediastinoscope | Aegis Surgical, Ltd. | 2015 | — |
| −1 | K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016 | — |
| 0 (this device) | K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017 | — |
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? (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 |
|---|---|---|---|
| * | K141622 | Illuminated MediastinoscopeSummary page 4…e Device Name of Device: Aegis Surgical, Ltd., Illuminated Mediastinal Access Port 510(k) Number: K141622 and K160171 1.4 Device Description The proposed Aegis Transit System introduces modifications to the Instructions fo… | 2015 |
| * | K160171 | Illuminated Mediastinal Access PortSummary page 4…Name of Device: Aegis Surgical, Ltd., Illuminated Mediastinal Access Port 510(k) Number: K141622 and K160171 1.4 Device Description The proposed Aegis Transit System introduces modifications to the Instructions for Use to… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K141622.
How does its category compare?
All EWY devicesEWY Mediastinoscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).
The Aegis Transit System 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/K170757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170757: Aegis Transit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170757
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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