510(k) · Cleared
ClearedHD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Sep 26, 2008 after a 176-day review. The FDA summary names its predicate without a number. 54 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 176 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 4 citing it directly.
- This deviceK080948 HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VHOlympus Medical Systems Corporation · 2008
- Descendant · cites it directly · 34 of its ownK111425 Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · Recalled
- Descendant · cites it directly · 33 of its ownK102379 LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011
- Descendant · 2 generations on · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
- Descendant · 2 generations on · 12 of its ownK113203 Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK111788 Endoeye HD IIOlympus America, Inc. · 2012 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp. · 2012 · cites it directly34descendants
- K102379LTF-Y0009; Maj-YOO41; Xoev-3D1Olympus Medical Systems Corporation · 2011 · cites it directly33descendants
- K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · 2 generations on19descendants
- K113203Sony LMD-2451MT LCD MonitorSony Electronics, Inc. · 2012 · 2 generations on12descendants
- K111788Endoeye HD IIOlympus America, Inc. · 2012 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080948 | HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH | Olympus Medical Systems Corporation | 2008 | — |
| +1 | K111425 | Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 | Olympus Medical Systems Corp. | 2012 | 1 |
| +1 | K102379 | LTF-Y0009; Maj-YOO41; Xoev-3D1 | Olympus Medical Systems Corporation | 2011 | — |
| +2 | K123365 | Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 | Olympus Medical Systems Corp. | 2013 | — |
| +2 | K113203 | Sony LMD-2451MT LCD Monitor | Sony Electronics, Inc. | 2012 | — |
| +1 | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | — | LTF-V Named without a submission number |
What descends from it? (54)
See all 544 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111425 (Olympus Medical Systems Corp., 2012) has gone furthest, with 34 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080948: HD Endoeye Laparo-Thoraco Videoscope Olympus LTF Type VH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080948
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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