510(k) · Cleared
ClearedKARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Dec 5, 2025 as substantially equivalent to K212656 (Karl Storz Endoscopy America, 2021) after a 182-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Dec 5, 2025
- Review
- 182 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071530 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK071530 Karl Storz Video Flexible Video Ent Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2007
- 1 generation backK212656 Flexible Intubation Video Endoscope – Sterile (FIVE-S)Karl Storz Endoscopy America · 2021 · Recalled
- This deviceK251731 KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S)…Karl Storz SE & CO. KG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071530 | Karl Storz Video Flexible Video Ent Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| −1 | K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | Karl Storz Endoscopy America | 2021 | 2 |
| 0 (this device) | K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | 2025 | — |
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 |
|---|---|---|---|
| * | K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S)Summary page 5…nce Document: Not Applicable Predicate Device: Predicate device: KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (K212656). Device Description: The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile… | 2021 |
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 18 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251731: KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251731
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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