510(k) · Cleared
ClearedHD 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 Jun 23, 2022 as substantially equivalent to K954910 (KARL STORZ Endoscopy-America, Inc., 1995) after a 267-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jun 23, 2022
- Review
- 267 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954910 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954910 Karl Storz Optical MediastinoscopeKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK213194 HD MediastinoscopeKarl Storz Endoscopy America, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260003 KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K954910 | Karl Storz Optical Mediastinoscope | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022 | — |
| +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 |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K954910 | Karl Storz Optical MediastinoscopeSummary page 4…es (21 CFR 874.4720) Regulatory Class: II Product Code: EWY Classification ENT Panel: Predicate Predicate Device: Optical Mediastinoscope (K954910) Device(s): Reference Devices: HOPKINS I & II Rigid Autoclavable Telescope (K935279), C- cam (K1… | 1995 |
| † | K935279 | Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid… | 1994 |
| † | K143640 | KSEA CMOS Camera System (C-cam) | 2015 |
| † | K202272 | HD Mediastinoscope | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and Instruments | 2026 | 0 |
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. 2022, 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 HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213194: HD Mediastinoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213194
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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