510(k) · Cleared
ClearedSystems Integration Model: Endoalpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · ODA Endoscopic Central Control Unit
Cleared on Mar 22, 2010 as substantially equivalent to K051613 (Olympus Medical Systems Corporation, 2005) after a 45-day review. Its family tree reaches back 7 generations to 1980. 1 later device descends from it.
- Decided
- Mar 22, 2010
- Review
- 45 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K801623 (1980). 27 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 5 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 4 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 3 generations backK022270 Modification to Olympus Integrated Endosurgery System EndoalphaOlympus Optical Co., Ltd. · 2002
- 2 generations backK041494 Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Olympus Corporation · 2004
- 1 generation backK051613 Modification to Olympus Integrated Endosurgery System Endoalpha…Olympus Medical Systems Corporation · 2005
- This deviceK100345 Systems Integration Model: EndoalphaOlympus Medical Systems Corporation · 2010
- Descendant · cites it directly · 0 of its ownK102763 Systems IntegrationOlympus Medical Systems Corporation · 2011
Most influential descendants
Showing 1 of 1 · See all- K102763Systems IntegrationOlympus Medical Systems Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −6 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −5 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −4 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −3 | K022270 | Modification to Olympus Integrated Endosurgery System Endoalpha | Olympus Optical Co., Ltd. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K100345 | Systems Integration Model: Endoalpha | Olympus Medical Systems Corporation | 2010 | — |
| +1 | K102763 | Systems Integration | Olympus Medical Systems Corporation | 2011 | — |
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 |
|---|---|---|
| 2011 | 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 ODA? 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 ODA device
- #1 K203566 Tablet Applicationscore 6.7 · 9 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 |
|---|---|---|---|
| * | K051613 | Modification to Olympus Integrated Endosurgery System Endoalpha (Control Unit for…Summary page 5…43 3 Predicate Device Information B Device Name: Olympus Integrated Endosurgery System EndoALPHA {Control Unit for Endosurgery UCES-2) Software Version 3 N 510(k) No: K051613 W Decision Date: 08/15/2005 4 Device Description The Systems Integration ENDOALPHA has been designed to be used with an Olympu… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102763 | Systems Integration | 2011 | 0 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K102763 (Olympus Medical Systems Corporation, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051613.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ODA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · ODA
Too few ODA 510(k)s in any year since 2007 to give a median.
Recalls per year · ODA
No recall names ODA since 2007.
Adverse event reports per year · ODA
3in 2025
MAUDE reports naming product code ODA, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100345: Systems Integration Model: Endoalpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100345
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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