510(k) · Cleared
ClearedENTity USB Videoscope 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 May 14, 2026 as substantially equivalent to K200609 (Optim, LLC, 2021) after a 143-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- May 14, 2026
- Review
- 143 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
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 backK200609 ENTity WiFi Video Nasopharyngoscope SystemOptim, LLC · 2021
- This deviceK254133 ENTity USB Videoscope SystemOptim, LLC · 2026
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 | K200609 | ENTity WiFi Video Nasopharyngoscope System | Optim, LLC | 2021 | — |
| 0 (this device) | K254133 | ENTity USB Videoscope System | Optim, LLC | 2026 | — |
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 |
|---|---|---|---|
| * | K200609 | ENTity WiFi Video Nasopharyngoscope SystemSummary page 5…0 Product Code: EOB Device Classification: Class II Reviewing Panel: Ear, Nose & Throat Devices 510(k) Number: K200609 Indications for Use: For oral or nasal introduction for the examination of the upper a… | 2021 |
| † | K222587 | PatCom Distal Chip Endoscope | 2023 |
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 19 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Optim ENTity USB Videoscope 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 as stated in the FDA summary.
https://510kreport.com/device/K254133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254133: ENTity USB Videoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254133
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026