510(k) · Cleared
ClearedUltrasound Gastroscope GF Type UM30P
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 Feb 7, 1997 as substantially equivalent to K926514 (Olympus Corp., 1993) after a 186-day review. Its family tree reaches back 1 generation to 1993. 1 of the 90 devices in its family, counting itself, has a Class I recall. 88 later devices descend from it.
- Decided
- Feb 7, 1997
- Review
- 186 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926514 (1993). 88 later devices descend from it, 2 citing it directly. 1 of the 90 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- This deviceK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 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 · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 3 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 27 of its ownK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
Showing 5 of 88 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 88 · See all- 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
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 2 generations on43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 3 generations on28descendants
- K994373Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer…Atl Ultrasound, Inc. · 2000 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| 0 (this device) | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| +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 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +3 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 1 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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 16.5 · 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 |
|---|---|---|---|
| * | K926514 | Endoscopic Ultrasound System Type 20Summary page 1…scope and related ancillary equipment Common/Usual Name: Olympus Ultrasonic Endoscopes Classification Name: Endoscope and Accessories Predicate Devices: GF/JF/CF-UM20 (K926514) Submitted By: Mr. Subhash Patel (Contact Person) Olympus America Inc. Regulatory Affairs 2 Corporate Center Drive Melville, NY… | 1993 |
What descends from it? (88)
See all 882 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- 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?
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?
The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20 or EU-M30, for endoscopic ultrasound irnaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.
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/K963023 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963023: Ultrasound Gastroscope GF Type UM30P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963023
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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