510(k) · Cleared
Recalled · Class II · 2020Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Jul 25, 1997 as substantially equivalent to K926514 (Olympus Corp., 1993) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1986. 1 of the 80 devices in its family, counting itself, has a Class I recall. 75 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 25, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- FDS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K853585 (1986). 4 ancestors in all. 75 later devices descend from it, 4 citing it directly. 1 of the 80 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 1 generation backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- This deviceK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997
- Descendant · cites it directly · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
- Descendant · cites it directly · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- Descendant · 2 generations on · 44 of its ownK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- Descendant · 2 generations on · 44 of its ownK021204 Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
- Descendant · 2 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX6 generations on · 2020
Most influential descendants
Showing 5 of 75 · See all- K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · cites it directly60descendants
- K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · cites it directly59descendants
- K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003 · 2 generations on44descendants
- K021204Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002 · 2 generations on44descendants
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 2 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −1 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| 0 (this device) | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | — |
| +1 | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | 1 |
| +1 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| +2 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| +2 | K021204 | Olympus BF Type UM40 | Olympus Optical Co., Ltd. | 2002 | — |
| +2 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 1 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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.
1 device in this family has 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.4 · 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? (2)
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 |
|---|---|---|---|
| * | K926514 | Endoscopic Ultrasound System Type 20Summary page 3…21 CFR 876.1500 Endoscope and Accessories. Class II, 21 CFR 892-1560 Ultrasonic Pulsed Echo Imaging System Predicate Devices: Olympus GF-UM20 Ultrasound Gastroscope (K926514) Olympus GIF Type 140 Series Gastrovideoscopes (K954451) Prepared & Submitted By: Mr. Subhash Patel (Contact Person) Olympus Am… | 1993 |
| * | K954451 | Evis 140 SystemSummary page 3…21 CFR 892-1560 Ultrasonic Pulsed Echo Imaging System Predicate Devices: Olympus GF-UM20 Ultrasound Gastroscope (K926514) Olympus GIF Type 140 Series Gastrovideoscopes (K954451) Prepared & Submitted By: Mr. Subhash Patel (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Center Dri… | 1996 |
What descends from it? (75)
See all 754 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | 2001 | 60 |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | 2001 | 59 |
| K051541 | GF-UE160-AL5 Ultrasound Endoscope | 2005 | 27 |
| K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope | 2007 | 15 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Class II | Z-0503-2021 | Device Design | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections. |
| Oct 16, 2020 | Class II | Z-0502-2021 | Device Design | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections. |
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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K011886 (Olympus America, Inc., 2001) has gone furthest, with 60 descendants of its own.
- 5 other devices also cite its predicate K926514.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
Olympus GF-UM130 Ultrasound Gastroscope has been designed to be used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.
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/K971660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971660
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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