510(k) · Cleared
ClearedZsquare ENT-Flex Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zsquare, Ltd. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Jun 14, 2022 as substantially equivalent to K162916 (3nt Medical, Ltd., 2017) and 1 other predicate after a 161-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Jun 14, 2022
- Review
- 161 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931154 (1993). 36 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 4 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 3 generations backK070752 Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007
- 2 generations backK082569 Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008
- 1 generation backK162916 3NT endoscopy system3nt Medical, Ltd. · 2017
- This deviceK220004 Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −3 | K070752 | Ksea Miniature Endoscope, Model 11565 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −2 | K082569 | Entellus Medical Flexible Endoscope and Eyepiece | Entellus Medical, Inc. | 2008 | — |
| −1 | K162916 | 3NT endoscopy system | 3nt Medical, Ltd. | 2017 | — |
| 0 (this device) | K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K162916 | 3NT endoscopy systemSummary page 4…assification Name Ear & Nose Surgery Product Code EOB Classification Class II Predicate Device 3NT endoscopy system (K162916), Ambu aScope 4 RhinoLaryngo Slim (K191080) Device Description Zsquare ENT-Flex endos… | 2017 |
| * | K191080 | Ambu aScope 4 RhinoLaryngo SlimSummary page 4…Classification Class II Predicate Device 3NT endoscopy system (K162916), Ambu aScope 4 RhinoLaryngo Slim (K191080) Device Description Zsquare ENT-Flex endoscope is a flexible, high-resolution endosco… | 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 8 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 36 ancestors have a recall of any class.
- 2 other devices also cite its predicate K162916.
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?
Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220004: Zsquare ENT-Flex Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220004
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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