510(k) · Cleared
ClearedKARL STORZ Mediastinoscopes and Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · EWY Mediastinoscope, Surgical
Cleared on Mar 2, 2026 as substantially equivalent to K954910 (KARL STORZ Endoscopy-America, Inc., 1995) and 2 other predicates after a 59-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 2, 2026
- Review
- 59 days
- Class
- Class II
- Product code
- EWY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954910 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK260003 KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KG · 2026
View 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) | K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 K213194 HD Mediastinoscopescore 6.6 · 1 generation · no Class I recall
- #2 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 5…tinoscopes and Accessories) Regulatory Class: II Product Code: EWY Classification Ear Nose & Throat Panel: Predicate KSEA Optical Mediastinoscope for ENT (K954910) Device(s): Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166)… | 1995 |
| * | K971166 | Optical Mediastinoscope with Plug-in Connection/Ocular EyepieceSummary page 5…el: Predicate KSEA Optical Mediastinoscope for ENT (K954910) Device(s): Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166) HD Mediastinoscope (K213194) Device The Mediastinoscopes and Instruments submitted in this 510(k) c… | 1997 |
| * | K213194 | HD MediastinoscopeSummary page 5…ope for ENT (K954910) Device(s): Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (K971166) HD Mediastinoscope (K213194) Device The Mediastinoscopes and Instruments submitted in this 510(k) consist of Description: two (2) variants of… | 2022 |
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 31 years and passes through 3 companies; a new generation was cleared every 28.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K954910.
How does its category compare?
All EWY devicesEWY Mediastinoscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
For devices (10970A, 10970B, 10970DS, 10973HD)
Intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during endoscopic surgical procedures in adults and pediatric patients = 12 years of age.
For devices (10900G0O,10900GP, 10900GR, 10900M, 10900MO, 10900MP, 10970, 10970G0O, 10970GOL,
10970GP, 10970GPL, 10970GR, 10970GRL, 10970H, 10970K, 10970M, 10970ML)
The instruments are intended for lymph node biopsy, removal of lymphatic nodes and tumors, grasping and dissecting tissue for diagnosis and treatment of pleural, parenchymal and mediastinal disease in adults and pediatric patients = 12 years of age.
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/K260003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260003: KARL STORZ Mediastinoscopes and Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260003
Report an extraction error
Are you the manufacturer?
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