510(k) · Cleared
Recalled · Class II · 2023Flexible Intubation Video Endoscope – Sterile (FIVE-S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Dec 29, 2021 as substantially equivalent to K071530 (KARL STORZ Endoscopy-America, Inc., 2007) after a 128-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 29, 2021
- Review
- 128 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071530 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK071530 Karl Storz Video Flexible Video Ent Endoscope SystemKARL STORZ Endoscopy-America, Inc. · 2007
- This deviceK212656 Flexible Intubation Video Endoscope – Sterile (FIVE-S)Karl Storz Endoscopy America · 2021
- Descendant · cites it directly · 0 of its ownK251731 KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S)…Karl Storz SE & CO. KG · 2025
Most influential descendants
Showing 1 of 1 · See all- K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)Karl Storz SE & CO. KG · 2025 · cites it directly0descendants
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) | K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | Karl Storz Endoscopy America | 2021 | — |
| +1 | K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | Karl Storz SE & CO. KG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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…EOQ Guidance Document: Not Applicable Predicate Device: Predicate device: KARL STORZ Flexible Video ENT Endoscope System (K071530). Reference devices: KARL STORZ CMOS Video Rhino- Laryngoscope SSU (K192090). KARL STORZ Flexible HD Cys… | 2007 |
| † | K192090 | CMOS Video Rhino-Laryngoscope SSU | 2020 |
| † | K182723 | Flexible HD Cysto-Urethroscope System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2023 | Class II | Z-2589-2023 | Process change control | Flexible intubation endoscopes sterility assurance can not be confirmed. |
| Apr 1, 2022 | Class II | Z-1055-2022 | Under Investigation by firm | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
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. 2021, 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) are intended for use by physicians for endotracheal intubation and 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.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
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/K212656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212656: Flexible Intubation Video Endoscope – Sterile (FIVE-S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212656
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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