510(k) · Cleared
Recalled · Class II · 2023GF-UE160-AL5 Ultrasound Endoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Jul 1, 2005 as substantially equivalent to K011314 (Aloka Co., Ltd., 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 3 generations to 1986. 27 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 1, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- FDF
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K853585 (1986). 6 ancestors in all. 27 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- This deviceK051541 GF-UE160-AL5 Ultrasound EndoscopeOlympus America, Inc. · 2005
- Descendant · cites it directly · 15 of its ownK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- Descendant · cites it directly · 8 of its ownK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK121564 Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation · 2007 · cites it directly15descendants
- K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc. · 2007 · cites it directly8descendants
- K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011 · 2 generations on7descendants
- K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · 2 generations on7descendants
- K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| 0 (this device) | K051541 | GF-UE160-AL5 Ultrasound Endoscope | Olympus America, Inc. | 2005 | — |
| +1 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| +1 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| +2 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| +2 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +2 | K121564 | Endoscopic Ultrasound Center EU-Y0006 | Olympus Medical Systems Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 FDF? 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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 |
|---|---|---|---|
| * | K011314 | Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System | 2001 |
| * | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Summary page 2…y 3. Predicate Devices: The Olympus GF-IJE I60-AL5 Endoscope is substantially equivalent to the Olympus GF-UCI14OP-AL5 Endoscope (K01I 1314) and the GF-UMI30 Endoscope (K971660). Both predicates share common indications and some features. 4. Device Description: The Olympus GF-UC14OP-AI5 is an electronic… | 1997 |
What descends from it? (27)
See all 273 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0333-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
| Oct 16, 2020 | Class II | Z-0507-2021 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K063683 (Olympus Medical Systems Corporation, 2007) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K011314.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. The Aloka SSD-5000 (K033311) is an all-digital diagnostic ultrasonic scanner with a digital beam former supporting gray scale, spectral Doppler and…
Read the full statement (136 words)
The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
The Aloka SSD-5000 (K033311) is an all-digital diagnostic ultrasonic scanner with a digital beam former supporting gray scale, spectral Doppler and Color Flow imaging. Depending on the probe, the Aloka SSD-5000 may be used for diagnostic ultrasound imaging in Cardiac, Gynecological, Neurological, Obstetrical, Neonatal, Pediatric, Perinatal, Radiological, Vascular, Urological, Trauma and Surgical applications. The Aloka SSD-5000 is a Track 3 system and is not indicated for ophthalmic applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051541: GF-UE160-AL5 Ultrasound Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051541
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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