510(k) · Cleared
ClearedENTity WiFi Video Nasopharyngoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optim, LLC · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jan 13, 2021 as substantially equivalent to K103467 (KARL STORZ Endoscopy-America, Inc., 2012) after a 310-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Jan 13, 2021
- Review
- 310 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072387 (2007). 1 later device descends from it, 1 citing it directly.
- 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 deviceK200609 ENTity WiFi Video Nasopharyngoscope SystemOptim, LLC · 2021
- Descendant · cites it directly · 0 of its ownK254133 ENTity USB Videoscope SystemOptim, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K254133ENTity USB Videoscope SystemOptim, LLC · 2026 · cites it directly0descendants
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) | K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | 2021 | — |
| +1 | K254133 | ENTity USB Videoscope System | Optim, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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…21 CFR 874.4760 Product Code: EOB Device Classification: Class II Reviewing Panel: Ear, Nose & Throat Devices 510(k) Number: K103467 Indications for Use: For endoscopic diagnosis within the nasal lumens and airway anatomy, and is… | 2012 |
| † | K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254133 | ENTity USB Videoscope System | 2026 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K254133 (Optim, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2021, 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 ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
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/K200609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200609: ENTity WiFi Video Nasopharyngoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200609
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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