510(k) · Cleared
ClearedKsea Miniature Endoscope, Model 11565
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on May 1, 2007 as substantially equivalent to K911278 (Olympus Corp., 1991) and 3 other predicates after a 43-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it.
- Decided
- May 1, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K931154 (1993). 13 ancestors in all, the oldest K850978 (1985). 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 4 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 3 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 2 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 1 generation backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- This deviceK070752 Ksea Miniature Endoscope, Model 11565KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK082569 Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK162916 3NT endoscopy system3nt Medical, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK220004 Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK202727 Peregrine Endoscopy System3nt Medical, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK192305 Colibri Endoscopy System3nt Medical, Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc. · 2008 · cites it directly5descendants
- K1629163NT endoscopy system3nt Medical, Ltd. · 2017 · 2 generations on3descendants
- K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd. · 2022 · 3 generations on0descendants
- K202727Peregrine Endoscopy System3nt Medical, Ltd. · 2021 · 3 generations on0descendants
- K192305Colibri Endoscopy System3nt Medical, Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −4 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −3 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −2 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −1 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| 0 (this device) | K070752 | Ksea Miniature Endoscope, Model 11565 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | K082569 | Entellus Medical Flexible Endoscope and Eyepiece | Entellus Medical, Inc. | 2008 | — |
| +2 | K162916 | 3NT endoscopy system | 3nt Medical, Ltd. | 2017 | — |
| +3 | K220004 | Zsquare ENT-Flex Endoscope | Zsquare, Ltd. | 2022 | — |
| +3 | K202727 | Peregrine Endoscopy System | 3nt Medical, Ltd. | 2021 | — |
| +3 | K192305 | Colibri Endoscopy System | 3nt Medical, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K911278 | Olympus AF Angioscope SystemSummary page 1…Nasopharyngoscope (flexible or rigid) and accessories Regulation Number: 21 CFR 874.4760 Product Code: EOB Predicate Device(s): Olympus Angioscope (K91 1278) Olympus ENF Type XP Rhino-Laryngo Fiberscope (K0l 3591, K01 1869) KSEA Sialoendl… | 1991 |
| * | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | 2001 |
| * | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary EquipmentSummary page 1….4760 Product Code: EOB Predicate Device(s): Olympus Angioscope (K91 1278) Olympus ENF Type XP Rhino-Laryngo Fiberscope (K0l 3591, K01 1869) KSEA Sialoendloscope (K012527) Device Description: The KSEA Miniature Endoscope is a manually opera… | 2001 |
| * | K012527 | Ksea Sialoendoscopes and AccessoriesSummary page 1…Olympus Angioscope (K91 1278) Olympus ENF Type XP Rhino-Laryngo Fiberscope (K0l 3591, K01 1869) KSEA Sialoendloscope (K012527) Device Description: The KSEA Miniature Endoscope is a manually operated, reusable surgical device t… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082569 | Entellus Medical Flexible Endoscope and Eyepiece | 2008 | 5 |
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 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K082569 (Entellus Medical, Inc., 2008) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K911278.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.
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/K070752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070752: Ksea Miniature Endoscope, Model 11565.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070752
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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