510(k) · Cleared
Recalled · Class II · 2023Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Aug 29, 2019 as substantially equivalent to K111788 (Olympus America, Inc., 2012) after a 160-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2019
- Review
- 160 days
- Class
- Class II
- Product code
- HET
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955456 (1996). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- 1 generation backK111788 Endoeye HD IIOlympus America, Inc. · 2012 · Recalled
- This deviceK190744 Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)Olympus Winter & Ibe GmbH · 2019
- 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 · 4 generations on · 0 of its ownK262079 4K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026
- Descendant · 4 generations on · 0 of its ownK251336 VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)…Olympus Medical Systems Corp. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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
- K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026 · 4 generations on0descendants
- K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955456 | Oes Laparo-Thoraco Videoscope (Rigid) | Olympus America, Inc. | 1996 | — |
| −1 | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | 2 |
| 0 (this device) | K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019 | — |
| +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 | — |
| +4 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | 2026 | — |
| +4 | K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE… | Olympus Medical Systems Corp. | 2025 | — |
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 |
|---|---|---|
| 2020 | 3 | 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? (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 |
|---|---|---|---|
| * | K111788 | Endoeye HD IISummary page 4…roduct code: HET GCJ / NWB Review Panel: Obstetrics and Gynecology 3 Predicate Device Olympus K111788, ENDOEYE HD II The predicate has been subject to a design related recall.… | 2012 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193026 | Visera Elite II Video System Center, Visera Elite II Endoeye 3D | 2020 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2023 | Class II | Z-0697-2024 | Component design/selection | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 15.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K193026 (Olympus Medical Systems Corp., 2020) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K111788.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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/K190744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190744: Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190744
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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