510(k) · Cleared
ClearedOlympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Jul 1, 2004 as substantially equivalent to K022270 (Olympus Optical Co., Ltd., 2002) after a 27-day review. Its family tree reaches back 5 generations to 1980. 6 later devices descend from it.
- Decided
- Jul 1, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801623 (1980). 25 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 4 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 3 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 2 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 1 generation backK022270 Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd. · 2002
- This deviceK041494 Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Corporation · 2004
- Descendant · cites it directly · 5 of its ownK051613 Modification to Olympus Integrated Endosurgery System Endoalpha…Olympus Medical Systems Corporation · 2005
- Descendant · 2 generations on · 2 of its ownK100852 Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010
- Descendant · 3 generations on · 1 of its ownK123426 Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK100345 Systems Integration Model: EndoalphaOlympus Medical Systems Corporation · 2010
- Descendant · 4 generations on · 0 of its ownK151737 MedicVOD SystemOrpheus Medical, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K051613Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Medical Systems Corporation · 2005 · cites it directly5descendants
- K100852Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000Stryker Communications · 2010 · 2 generations on2descendants
- K123426Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSSOrpheus Medical, Ltd. · 2013 · 3 generations on1descendant
- K100345Systems Integration Model: EndoalphaOlympus Medical Systems Corporation · 2010 · 2 generations on1descendant
- K151737MedicVOD SystemOrpheus Medical, Ltd. · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −4 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −3 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −2 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −1 | K022270 | Modification to Olympus Integrated Endosurgery System Endoalpha | Olympus Optical Co., Ltd. | 2002 | — |
| 0 (this device) | K041494 | Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery… | Olympus Corporation | 2004 | — |
| +1 | K051613 | Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit… | Olympus Medical Systems Corporation | 2005 | — |
| +2 | K100852 | Stryker Switchpoint Infinity 3 Control System, Model: 067-8001-000 | Stryker Communications | 2010 | — |
| +3 | K123426 | Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS | Orpheus Medical, Ltd. | 2013 | — |
| +2 | K100345 | Systems Integration Model: Endoalpha | Olympus Medical Systems Corporation | 2010 | — |
| +4 | K151737 | MedicVOD System | Orpheus Medical, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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 |
|---|---|---|---|
| * | K022270 | Modification to Olympus Integrated Endosurgery System EndoalphaSummary page 2…Class II C. Predicate Device Information 33 1. Trade Name: #K022270 OLYMPUS INTEGRATED ENDOSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR… | 2002 |
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 |
|---|---|---|---|
| K051613 | Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for… | 2005 | 5 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K051613 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K022270.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
The 'OLYMPUS INTEGRATED ENDSURGERY SYSTEM EndoALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2)"has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, interlocking operation of the ancillary equipment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041494: Olympus Integrated Endosurgery System Endoalpha (Control Unit for Endosurgery Uces-2) Software Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041494
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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