510(k) · Cleared
ClearedHD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · NWB Endoscope, Accessories, Narrow Band Spectrum
Cleared on Jun 29, 2009 as substantially equivalent to K955456 (Olympus America, Inc., 1996) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 29, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- NWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955456 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- This deviceK090980 HD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015LOlympus Winter & Ibe GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955456 | Oes Laparo-Thoraco Videoscope (Rigid) | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K090980 | HD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | Olympus Winter & Ibe GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 NWB? 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 NWB device
- #1 K211882 HD-550 Video Endoscope Systemscore 8.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K955456 | Oes Laparo-Thoraco Videoscope (Rigid)Summary page 2…laim substantial equivalence. Table 11.1 Subject & Predicate Devices HO EndoEYE A4941A, A4943A OES Laparo-Thoraco K955456 WA50011A, WA50013A, Vdeosco WA50013L, WA50013T, WA50015L Laparo-Thoraco… | 1996 |
| * | K080948 | HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VHSummary page 2…A50013L, WA50013T, WA50015L Laparo-Thoraco HD EndoEYEOLYMPUS K080948 Videoscope LTF-VH 4. Device Description The HD EndoEYE - High Definiti… | 2008 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K955456.
How does its category compare?
All NWB devicesNWB Endoscope, Accessories, Narrow Band Spectrum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NWB
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NWB
Too few NWB 510(k)s in any year since 2007 to give a median.
Recalls per year · NWB
5in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NWB
2,847in 2025
MAUDE reports naming product code NWB, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 1 | — | 3 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 823 |
| 2021 | 0 | — | 0 | 1,453 |
| 2022 | 2 | — | 0 | 1,828 |
| 2023 | 0 | — | 5 (2) | 2,180 |
| 2024 | 0 | — | 0 | 2,648 |
| 2025 | 0 | — | 0 | 2,847 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrsurgical unit and other ancillary equipment for endoscopic diagnosis and treatment within the abdomen and thoracic cavities including the female reproductive organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090980: HD Endoeye, Models WA50011A, WA50013A, WA50013L, WA50013T, WA50015L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090980
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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