510(k) · Cleared
ClearedPENTAX Medical VIVIDEO ENT Videoscope Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jul 18, 2018 as substantially equivalent to K103467 (KARL STORZ Endoscopy-America, Inc., 2012) after a 470-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Jul 18, 2018
- Review
- 470 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072387 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK072387 Karl Storz Video Rhino-Laryngscope System, Model 11101 SeriesKARL STORZ Endoscopy-America, Inc. · 2007
- 1 generation backK103467 Cmos Video Rhino-Laryngoscope System Model 11101CMKARL STORZ Endoscopy-America, Inc. · 2012
- This deviceK171011 PENTAX Medical VIVIDEO ENT Videoscope SolutionPentax Medical · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072387 | Karl Storz Video Rhino-Laryngscope System, Model 11101 Series | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −1 | K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CM | KARL STORZ Endoscopy-America, Inc. | 2012 | — |
| 0 (this device) | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | Pentax Medical | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K103467 | Cmos Video Rhino-Laryngoscope System Model 11101CMSummary page 4…gulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Predicate Device: KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System (K103467, clearance received on June 28, 2012) Device Description: The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the video… | 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 11 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K103467.
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 PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords.
This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171011: PENTAX Medical VIVIDEO ENT Videoscope Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171011
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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