510(k) · Cleared
Recalled · Class II · 2017Endoeye HD II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jan 13, 2012 as substantially equivalent to K955456 (Olympus America, Inc., 1996) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 13, 2012
- Review
- 203 days
- Class
- Class II
- Product code
- HET
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K955456 (1996). 2 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- This deviceK111788 Endoeye HD IIOlympus America, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK190744 Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH · 2019 · Recalled
- Descendant · cites it directly · 5 of its ownK193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 4 of its ownK201200 Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 2 of its ownK242067 Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite…Olympus Corporations of the Americas · 2025
- Descendant · cites it directly · 1 of its ownK190190 WV1 Endoscope270surgical, Ltd. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190744Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH · 2019 · cites it directly6descendants
- K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp. · 2020 · cites it directly5descendants
- K201200Visera Elite II Video System CenterOlympus Medical Systems Corp. · 2020 · 2 generations on4descendants
- K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas · 2025 · 3 generations on2descendants
- K190190WV1 Endoscope270surgical, Ltd. · 2019 · cites it directly1descendant
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) | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | — |
| +1 | K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019 | 1 |
| +1 | K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led… | Olympus Corporations of the Americas | 2025 | — |
| +1 | K190190 | WV1 Endoscope | 270surgical, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2025 | 2 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K095998 | HD EndoEYE Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K955456 | Oes Laparo-Thoraco Videoscope (Rigid)Summary page 3…Laparo-Thoraco Videoscope 510(k) number K955456 K080948 Type WA5004OA, WA5001 1lA, LTF-VH WASOO42A,… | 1996 |
| * | K080948 | HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VHSummary page 2…WA5001 1A, WA50013A, WASOO13L, autoclavable WA50013T, WA50015L - WA50042A, 10 mm, 300, HO EndoEYE Laparo-Thoraco K080948 autoclavable Videoscope OLYMPUS LTF-VH - WA5005OA, 5.4 mm, 00, autoclavable - WA50052A, 5.4 mm, 3… | 2008 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2017 | Class II | Z-1929-2017 | Device Design | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| Nov 17, 2015 | Class II | Z-0403-2016 | Unknown/Undetermined by firm | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 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, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111788: Endoeye HD II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111788
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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