510(k) · Cleared
ClearedFlexible Tip Thoracoscope/Laparoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Mar 11, 1994 after an 805-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 79 later devices descend from it.
- Decided
- Mar 11, 1994
- Review
- 805 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
79 later devices descend from it, 3 citing it directly.
- This deviceK915857 Flexible Tip Thoracoscope/LaparoscopeOlympus Corp. · 1994
- Descendant · cites it directly · 67 of its ownK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- Descendant · 2 generations on · 63 of its ownK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 59 of its ownK073036 Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 59 of its ownK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- Descendant · 2 generations on · 58 of its ownK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K040684T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004 · cites it directly67descendants
- K051257Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005 · 2 generations on63descendants
- K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008 · 2 generations on59descendants
- K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006 · 2 generations on59descendants
- K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915857 | Flexible Tip Thoracoscope/Laparoscope | Olympus Corp. | 1994 | — |
| +1 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| +2 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| +2 | K073036 | Fore-Sight, MC-2000 Series | Cas Medical Systems, Inc. | 2008 | — |
| +2 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| +2 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (79)
See all 793 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, K040684 (Spectros Corporation, 2004) has gone furthest, with 67 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.
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 | — |
https://510kreport.com/device/K915857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915857: Flexible Tip Thoracoscope/Laparoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915857
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026