510(k) · Cleared
ClearedOlympus Integrated Endosurgery System Endoalpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · ODA Endoscopic Central Control Unit
Cleared on Aug 21, 1998 as substantially equivalent to K970184 (Olympus America, Inc., 1997) and 8 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1980. 4 of the 199 devices in its family, counting itself, have a Class I recall. 175 later devices descend from it.
- Decided
- Aug 21, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 3 generations to K801623 (1980). 23 ancestors in all. 175 later devices descend from it, 5 citing it directly. 4 of the 199 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 2 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 1 generation backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- This deviceK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- Descendant · cites it directly · 157 of its ownK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- Descendant · 2 generations on · 154 of its ownK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 72 of its ownK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 175 · See all- K994231Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000 · cites it directly157descendants
- K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on154descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on78descendants
- K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · 3 generations on72descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −2 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −1 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| +1 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| +2 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| +3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +3 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 11 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 14 | 1 |
| 2017 | 6 | 2 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 1 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 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.
4 devices in this family have a Class I recall. 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? (9)
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 |
|---|---|---|---|
| * | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesSummary page 2…ccessories foe 08/13/98 THU 18:59 FAX 516 844 5448 ED KGs1443 MODEL | NAME 510(k) Number UES-20 | Electrosurgical Unit and its associated accessories K970184 SonoSurg | SonoSurg System K972114 UHI UHI High Flow Insufflation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K… | 1997 |
| * | K972114 | Olympus Sonosurg SystemSummary page 2…13/98 THU 18:59 FAX 516 844 5448 ED KGs1443 MODEL | NAME 510(k) Number UES-20 | Electrosurgical Unit and its associated accessories K970184 SonoSurg | SonoSurg System K972114 UHI UHI High Flow Insufflation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K963184 . K971416 OTV-SX | Subcutane… | 1998 |
| * | K953163 | Quick Read 2000 (QR2000)Summary page 2…3 MODEL | NAME 510(k) Number UES-20 | Electrosurgical Unit and its associated accessories K970184 SonoSurg | SonoSurg System K972114 UHI UHI High Flow Insufflation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K963184 . K971416 OTV-SX | Subcutaneous Endoscopy System K963184 IU-E1 Laparosco… | 1995 |
| * | K963184 | Olympus Subcutaneous Endoscopy SystemSummary page 2…it and its associated accessories K970184 SonoSurg | SonoSurg System K972114 UHI UHI High Flow Insufflation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K963184 . K971416 OTV-SX | Subcutaneous Endoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultra… | 1996 |
| * | K971416 | Olympus Oes Otv-S5C Video SystemSummary page 2…associated accessories K970184 SonoSurg | SonoSurg System K972114 UHI UHI High Flow Insufflation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K963184 . K971416 OTV-SX | Subcutaneous Endoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultrasound Syst… | 1997 |
| * | K944017 | Olympus Laparoscopic Ultrasound SystemSummary page 2…ation Unit K953163 CLV-S20 | Subcutaneous Endoscopy System, OTV-S5C K963184 . K971416 OTV-SX | Subcutaneous Endoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultrasound System K944017 3DV 3D Surgical Endoscopy System K943304 K943305 | : K943307 Crystal 3D Surgical… | 1995 |
| * | K943304 | 3D Surgical Endoscopy System for UrologySummary page 2…-SX | Subcutaneous Endoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultrasound System K944017 3DV 3D Surgical Endoscopy System K943304 K943305 | : K943307 Crystal 3D Surgical Endoscopy System K943304 Eye E K943305 K943307 E. Description of the Device Olympus End… | 1995 |
| * | K943305 | Olympus 3D Surgical Endoscopy SystemSummary page 2…bcutaneous Endoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultrasound System K944017 3DV 3D Surgical Endoscopy System K943304 K943305 | : K943307 Crystal 3D Surgical Endoscopy System K943304 Eye E K943305 K943307 E. Description of the Device Olympus EndoAlpha I… | 1995 |
| * | K943307 | 3D Surgical Endoscopy System for General SurgerySummary page 2…ndoscopy System K963184 IU-E1 Laparoscopic Ultrasound System K944017 MB-631 | Laparoscopic Ultrasound System K944017 3DV 3D Surgical Endoscopy System K943304 K943305 | : K943307 Crystal 3D Surgical Endoscopy System K943304 Eye E K943305 K943307 E. Description of the Device Olympus EndoAlpha Integrated En… | 1995 |
What descends from it? (175)
See all 1755 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994231 | Siemens Integrated Operating System (Sios) | 2000 | 157 |
| K022270 | Modification to Olympus Integrated Endosurgery System Endoalpha | 2002 | 8 |
| K050209 | Smith & Nephew Control Digital Operating Room System | 2005 | 3 |
| K050829 | Nurse's Assistant 1.7 O.R. Control System | 2005 | 3 |
| K020255 | Riwo Net Operating Operating Control System, Model #5590 | 2002 | 1 |
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K994231 (Siemens Medical Corp., 2000) has gone furthest, with 157 descendants of its own.
- 3 other devices also cite its predicate K970184.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Olympus Integrated Endosurgery System EndoALPHA has been designed to be used
with an Olympus endoscope 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/K981993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981993: Olympus Integrated Endosurgery System Endoalpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981993
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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