510(k) · Cleared
ClearedKarl Storz Video Flexible Video Ent Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Aug 24, 2007 after an 80-day review. The FDA summary names no predicate by number. 26 later devices descend from it.
- Decided
- Aug 24, 2007
- Review
- 80 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 5 citing it directly.
- This deviceK071530 Karl Storz Video Flexible Video Ent Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK141366 Video Bronchoscope SystemScholly Fiberoptic GmbH · 2014
- Descendant · 2 generations on · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- Descendant · cites it directly · 7 of its ownK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K141366Video Bronchoscope SystemScholly Fiberoptic GmbH · 2014 · cites it directly13descendants
- K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · 2 generations on12descendants
- K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · cites it directly7descendants
- K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · 3 generations on5descendants
- K193534Monarch PlatformAuris Health, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071530 | Karl Storz Video Flexible Video Ent Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | K141366 | Video Bronchoscope System | Scholly Fiberoptic GmbH | 2014 | — |
| +2 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| +1 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| +3 | K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| +2 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 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 EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (26)
See all 265 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141366 | Video Bronchoscope System | 2014 | 13 |
| K173760 | Monarch Endoscopy Platform (Monarch Platform) | 2018 | 7 |
| K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | 2021 | 1 |
| K152319 | Auris Robotic Endoscopy System (ARES) | 2016 | 0 |
| K082038 | Clarus Video Airway Endoscope, Models 30000-V and 30003-V | 2009 | 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?
- Of its descendants, K141366 (Scholly Fiberoptic GmbH, 2014) has gone furthest, with 13 descendants of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (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 · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
The Karl Storz Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasal, sinus and nasopharyngeal endoscopy, bronchoscopy, tracheoscopy and esophagoscopy and laryngoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071530: Karl Storz Video Flexible Video Ent Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071530
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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