510(k) · Cleared
ClearedVideo Bronchoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scholly Fiberoptic GmbH · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Dec 17, 2014 as substantially equivalent to K071530 (KARL STORZ Endoscopy-America, Inc., 2007) after a 208-day review. Its family tree reaches back 1 generation to 2007. 13 later devices descend from it.
- Decided
- Dec 17, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071530 (2007). 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK071530 Karl Storz Video Flexible Video Ent Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2007
- This deviceK141366 Video Bronchoscope SystemScholly Fiberoptic GmbH · 2014
- Descendant · cites it directly · 12 of its ownK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- Descendant · 2 generations on · 5 of its ownK202370 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK220299 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK232984 Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK192367 Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K182188Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · cites it directly12descendants
- K202370Ion Endoluminal SystemIntuitive Surgical, Inc. · 2020 · 2 generations on5descendants
- K220299Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2022 · 3 generations on4descendants
- K232984Ion Endoluminal System (IF1000)Intuitive Surgical, Inc. · 2023 · 4 generations on3descendants
- K192367Ion Endoluminal SystemIntuitive Surgical, Inc. · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071530 | Karl Storz Video Flexible Video Ent Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| 0 (this device) | K141366 | Video Bronchoscope System | Scholly Fiberoptic GmbH | 2014 | — |
| +1 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| +2 | K202370 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2020 | — |
| +3 | K220299 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2022 | — |
| +4 | K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | 2023 | — |
| +2 | K192367 | Ion Endoluminal System | Intuitive Surgical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K071530 | Karl Storz Video Flexible Video Ent Endoscope SystemSummary page 4…Classification Name: EOQ – Bronchoscope (flexible or rigid) 21 CFR 874.4680; Class II Premarket Notification: K071530 (Karl Storz Endoscopy-America, Inc.), SE date August 24, 2007 In addition to the Karl Storz… | 2007 |
| † | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | 2013 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | 2019 | 12 |
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?
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Schoelly Video Bronchoscope System is intended for use by physicians for diagnostic and therapeutic procedures in nasopharyngeal endoscopy, bronchoscopy, tracheoscopy, and laryngoscopy. The Schoelly Video Bronchoscope is intended to provide visualization via a video monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141366: Video Bronchoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141366
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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