510(k) · Cleared
Recalled · Class II · 2022KARL STORZ Slim Nasopharyngolaryngoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Feb 2, 2018 as substantially equivalent to K981458 (Karl Storz Endoscopy, 1998) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Feb 2, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- EOB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945381 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK945381 Nasopharyngoscopes, Bronchoscopes, Tracheoscp[ES and Esophagoscopes…KARL STORZ Endoscopy-America, Inc. · 1995
- 1 generation backK030857 Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary…Mahe Intl., Inc. · 2003
- This deviceK171402 KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945381 | Nasopharyngoscopes, Bronchoscopes, Tracheoscp[ES and Esophagoscopes… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| −1 | K030857 | Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and… | Mahe Intl., Inc. | 2003 | — |
| 0 (this device) | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K981458 | Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and…Summary page 4…duct code Consensus Standards: Predicate Primary Predicate Device: KARL STORZ Endoscopy-America’s Device(s): Karl Storz Rhino-Laryngo-Broncho-Fiberscope (K981458) Secondary Predicate Device: MAHE INTL., INC’s MAHE Pediatric Naso Pharyngoscope (K030857)… | 1998 |
| * | K030857 | Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic…Summary page 4…rl Storz Rhino-Laryngo-Broncho-Fiberscope (K981458) Secondary Predicate Device: MAHE INTL., INC’s MAHE Pediatric Naso Pharyngoscope (K030857) Reference: KARL STORZ Endoscopy-America’s KARL STORZ Flexible Video-Neuro-Endoscope System… | 2003 |
| † | K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2022 | Class II | Z-1054-2022 | Under Investigation by firm | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K981458.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 KARL STORZ Slim Nasopharyngolaryngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171402: KARL STORZ Slim Nasopharyngolaryngoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171402
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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