510(k) · Cleared
ClearedENT Nasopharyngoscope and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaging Integrated Solution, Inc (Miis) · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jul 1, 2022 as substantially equivalent to K191080 (Ambu A/S, 2019) after a 186-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Jul 1, 2022
- Review
- 186 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931154 (1993). 11 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 3 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 2 generations backK181286 Ambu aScope RLS SlimAmbu A/S · 2018
- 1 generation backK191080 Ambu aScope 4 RhinoLaryngo SlimAmbu A/S · 2019
- This deviceK214050 ENT Nasopharyngoscope and AccessoriesMedimaging Integrated Solution, Inc (Miis) · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −3 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −2 | K181286 | Ambu aScope RLS Slim | Ambu A/S | 2018 | — |
| −1 | K191080 | Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S | 2019 | — |
| 0 (this device) | K214050 | ENT Nasopharyngoscope and Accessories | Medimaging Integrated Solution, Inc (Miis) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K191080 | Ambu aScope 4 RhinoLaryngo SlimSummary page 5…opharyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) Regulatory Class: Class II Product Code: EOB Predicate Device: K191080 Trade/Device Name: Ambu aScope 4 RhinoLaryngo Slim Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexibl… | 2019 |
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 29 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K191080.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy.
The Video Box EVS 100 is intended to provide visualization via the connected tablet.
The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.
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/K214050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214050: ENT Nasopharyngoscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214050
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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