510(k) Report

510(k) · Cleared

Cleared

Olympus MH-246R Balloon Sheath

K961048510(k) TraditionalCleared Sep 16, 1996185-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus America, Inc. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology

Cleared on Sep 16, 1996 as substantially equivalent to K872027 (Olympus Corp., 1987) and 2 other predicates after a 185-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.

Decided
Sep 16, 1996
Review
185 days
Class
Class II
Product code
ODG
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K872027 (1987). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1988: 1 other ancestor1998: 3 descendants cleared2000: 2 descendants clearedK872027 · Olympus GF-UM2/EU-M2 · Olympus Corp. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants K872027 · Olympus GF-UM2/EU-M2 · Olympus Corp. · 19870
  1. Root · 1 generation backK872027 Olympus GF-UM2/EU-M2Olympus Corp. · 1987
  2. This deviceK961048 Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996
  3. Descendant · cites it directly · 1 of its ownK982733 Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co. · 1998
  4. Descendant · cites it directly · 1 of its ownK982734 Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998
  5. Descendant · 2 generations on · 0 of its ownK994106 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
  6. Descendant · 2 generations on · 0 of its ownK994069 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
  7. Descendant · cites it directly · 0 of its ownK982725 Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc. · 1998

Most influential descendants

Showing 5 of 5 · See all
  • K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co. · 1998 · cites it directly1descendant
  • K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998 · cites it directly1descendant
  • K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial UseOlympus America, Inc. · 2000 · 2 generations on0descendants
  • K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseOlympus America, Inc. · 2000 · 2 generations on0descendants
  • K982725Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872027Olympus GF-UM2/EU-M2Olympus Corp.1987—
0 (this device)K961048Olympus MH-246R Balloon SheathOlympus America, Inc.1996—
+1K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.1998—
+1K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co.1998—
+2K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.2000—
+2K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.2000—
+1K982725Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199830
200020
FIG. 1 — Lineage of K961048, 1987–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K872027Olympus GF-UM2/EU-M2
Summary page 1
…P Device Name: Olympus MH-246R Balloon Sheath Common/Usual Name: Balloon Sheath Classification Name: Endoscope and Accessories Predicate Devices: Olympus GF-UM2/EU-M2 K872027 GF-UM-3/EU-M3 K&882061 EUS-20 System K926514 Submitted By: Mr. Barry Sands (Contact Person) Olympus America Inc. Endoscope Div…
Olympus Corp.1987—
*K882061Olympus GF-UM3/EU-M3
Summary page 1
…H-246R Balloon Sheath Common/Usual Name: Balloon Sheath Classification Name: Endoscope and Accessories Predicate Devices: Olympus GF-UM2/EU-M2 K872027 GF-UM-3/EU-M3 K&882061 EUS-20 System K926514 Submitted By: Mr. Barry Sands (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Cen…
Olympus Corp.1988—
*K926514Endoscopic Ultrasound System Type 20
Summary page 1
…Common/Usual Name: Balloon Sheath Classification Name: Endoscope and Accessories Predicate Devices: Olympus GF-UM2/EU-M2 K872027 GF-UM-3/EU-M3 K&882061 EUS-20 System K926514 Submitted By: Mr. Barry Sands (Contact Person) Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New…
Olympus Corp.19931

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.19981
K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co.19981
K982725Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseOlympus America, Inc.19980

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K982733 (The Olympus Optical Co., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All ODG devices

ODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ODG

2in 2025

2009: 22011: 22013: 22014: 12016: 12017: 42018: 32019: 12020: 22021: 12022: 42023: 12024: 12025: 22026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODG

71in 2022

2017: 75 days median2018: 30 days median2022: 71 days median
2007high 75 (2017) · low 30 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODG

4in 2020

2020: 42026 (partial year): 4
2007high 4 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODG

3,569in 2025

2008: 12009: 32010: 22011: 132012: 62013: 22014: 12015: 112016: 502017: 822018: 662019: 962020: 4452021: 1,2342022: 1,8322023: 2,0782024: 1,9042025: 3,569
2007high 3,569 (2025) · low 0 (2007)2025

MAUDE reports naming product code ODG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20092—03
20100—02
20112—013
20120—06
20132—02
20141—01
20150—011
20161—050
2017475082
2018330066
20191—096
20202—4445
20211—01,234
202247101,832
20231—02,078
20241—01,904
20252—03,569
20262—4—

What is it indicated for?

The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall 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.

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 recall

Recent decisions in ODG

The ODG category page

  • K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation · 2026
  • K260428RIVOS™ EUS Access Device (M00553900)Boston Scientific Corporation · 2026
  • K251859EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation · 2025
  • K251542InstaFANOnepass Medical, Ltd. · 2025
  • K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024

https://510kreport.com/device/K961048 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961048: Olympus MH-246R Balloon Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961048

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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