510(k) · Cleared
ClearedOlympus MH-246R Balloon Sheath, for Urinary Tract Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Oct 5, 1998 as substantially equivalent to K961048 (Olympus America, Inc., 1996) after a 61-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Oct 5, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872027 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872027 Olympus GF-UM2/EU-M2Olympus Corp. · 1987
- 1 generation backK961048 Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996
- This deviceK982734 Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998
- Descendant · cites it directly · 0 of its ownK994069 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseOlympus America, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872027 | Olympus GF-UM2/EU-M2 | Olympus Corp. | 1987 | — |
| −1 | K961048 | Olympus MH-246R Balloon Sheath | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K982734 | Olympus MH-246R Balloon Sheath, for Urinary Tract Use | The Olympus Optical Co. | 1998 | — |
| +1 | K994069 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | Olympus America, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 ODG? 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 ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 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 |
|---|---|---|---|
| * | K961048 | Olympus MH-246R Balloon SheathSummary page 1…ass I1, 21 CFR 892.1570, Diagnostic Ultrasound and Name: Transducer Class II, 21 CFR 876.1500 Endoscope & Accessories Predicate Devices: Olympus MH-246R (for GI use), K961048 Submitted by: Laura Storms-Tyler Olympus America Inc. Regulatory Affairs Two Corporate Drive Melville, NY 11747-3157 phone (51… | 1996 |
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 |
|---|---|---|---|
| K994069 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use | 2000 | 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 11 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K994069 (Olympus America, Inc., 2000) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K961048.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
Olympus MH-246R Balloon Sheath have been designed to be used with the
Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of
the urinary tract.
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/K982734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982734: Olympus MH-246R Balloon Sheath, for Urinary Tract Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982734
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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