# K954910: Karl Storz Optical Mediastinoscope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 3, 1995 after 9 days
- Product code: EWY (Mediastinoscope, Surgical)
- Device class: 2
- Regulation: 21 CFR 874.4720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971166: Optical Mediastinoscope with Plug-in Connection/Ocular Eyepiece (1997), 4 descendants of its own
- K141622: Illuminated Mediastinoscope (2015), 2 descendants of its own
- K213194: HD Mediastinoscope (2022), 1 descendant of its own
- K160171: Illuminated Mediastinal Access Port (2016), 1 descendant of its own
- K260003: KARL STORZ Mediastinoscopes and Instruments (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K954910
Methodology: https://510kreport.com/methodology