# K981458: Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001RK, 11002BC & 110

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: May 20, 1998 after 27 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051972: Karl Storz Trans-Nasal Esophagoscope (2005), 2 descendants of its own
- K223072: PENTAX Medical Video Esophagoscope EE17-J10 (2022), 0 descendants of its own
- K192523: CMOS Video Esophagoscope SSU (2020), 0 descendants of its own
- K171402: KARL STORZ Slim Nasopharyngolaryngoscope (2018), 0 descendants of its own

## Recalls of this device
- Nov 13, 2013 · Class II · Z-0527-2014: KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Intubation Fiberscope with a suction port because the material used in the suction channel portion was the

## Indications for use
The Rhino-Laryngo-Broncho-Fiberscope is indicated for examination of the nasal sinuses, larynx and bronchi and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Pediatric Broncho-Fiberscope is indicated for examination of the larynx and bronchi in pediatric patients and, using additional accessories, to perform various diagnostic and therapeutic procedures. The Broncho-Fiberscope is indicated for examination of the larynx and bronchi in adult patients and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K981458
Methodology: https://510kreport.com/methodology