510(k) · Cleared
ClearedHD Video Rhino Laryngoscope
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 Aug 11, 2020 as substantially equivalent to K182186 (KARL STORZ Endoscopy-America, Inc., 2019) and 1 other predicate after a 141-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Aug 11, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K072387 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK072387 Karl Storz Video Rhino-Laryngscope System, Model 11101 SeriesKARL STORZ Endoscopy-America, Inc. · 2007
- 2 generations backK103467 Cmos Video Rhino-Laryngoscope System Model 11101CMKARL STORZ Endoscopy-America, Inc. · 2012
- 1 generation backK182186 CMOS Video-Rhino-Laryngoscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- This deviceK200740 HD Video Rhino LaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072387 | Karl Storz Video Rhino-Laryngscope System, Model 11101 Series | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −2 | K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CM | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| −1 | K182186 | CMOS Video-Rhino-Laryngoscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| 0 (this device) | K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K182186 | CMOS Video-Rhino-Laryngoscope SystemSummary page 4…essential performance of endoscopic equipment Predicate Primary Predicate Device: KARL STORZ Endoscopy-America’s Device(s): CMOS Video Rhino Laryngoscope (K182186) Secondary Predicate Device: KARL STORZ Endoscopy-America’s Flexible CMOS-Video- Rhino-Laryn… | 2019 |
| * | K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CMSummary page 4…deo Rhino Laryngoscope (K182186) Secondary Predicate Device: KARL STORZ Endoscopy-America’s Flexible CMOS-Video- Rhino-Laryngoscope (K103467) Device The components subject of this submission are: the Flexible HD Description: Video-Rhino-Laryngoscope (Par… | 2012 |
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 13 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K182186.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 CMOS HD Video Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200740 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200740: HD Video Rhino Laryngoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200740
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