510(k) · Cleared
Recalled · Class II · 2013Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001RK, 11002BC & 110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on May 20, 1998 after a 27-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled once.
- Decided
- May 20, 1998
- Review
- 27 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK981458 Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope…Karl Storz Endoscopy · 1998
- Descendant · cites it directly · 2 of its ownK051972 Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK223072 PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192523 CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG · 2020
- Descendant · cites it directly · 0 of its ownK171402 KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2018 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc. · 2005 · cites it directly2descendants
- K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc. · 2022 · 2 generations on0descendants
- K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG · 2020 · 2 generations on0descendants
- K171402KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981458 | Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and… | Karl Storz Endoscopy | 1998 | — |
| +1 | K051972 | Karl Storz Trans-Nasal Esophagoscope | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +2 | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022 | — |
| +2 | K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020 | — |
| +1 | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2013 | Class II | Z-0527-2014 | Under Investigation by firm | 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 thermoplastic polyurethane (TPU), which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051972 (KARL STORZ Endoscopy-America, Inc., 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
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.
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/K981458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981458: Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and Broncho-Fiberscope,11001RK, 11002BC & 110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981458
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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