510(k) Report

510(k) · Cleared

Cleared

Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use

K994106510(k) TraditionalCleared Jun 2, 2000179-day reviewClass II21 CFR 892.1570

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

Olympus America, Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jun 2, 2000 as substantially equivalent to K982323 (Olympus America, Inc., 1998) and 3 other predicates after a 179-day review. Its family tree reaches back 3 generations to 1987.

Decided
Jun 2, 2000
Review
179 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K872027 (1987). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestorK872027 · Olympus GF-UM2/EU-M2 · Olympus Corp. · 1987K961048 · Olympus MH-246R Balloon Sheath · Olympus America, Inc. · 1996K982733 · Olympus MH-246R Balloon Sheath, for Bronchial Use · The Olympus Optical Co. · 19981985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors K982733 · Olympus MH-246R Balloon Sheath, for Bronchial Use · The Olympus Optical Co. · 1998K961048 · Olympus MH-246R Balloon Sheath · Olympus America, Inc. · 1996K872027 · Olympus GF-UM2/EU-M2 · Olympus Corp. · 19870
  1. Root · 3 generations backK872027 Olympus GF-UM2/EU-M2Olympus Corp. · 1987
  2. 2 generations backK961048 Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996
  3. 1 generation backK982733 Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co. · 1998
  4. This deviceK994106 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K872027Olympus GF-UM2/EU-M2Olympus Corp.1987—
−2K961048Olympus MH-246R Balloon SheathOlympus America, Inc.1996—
−1K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.1998—
0 (this device)K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199310
199510
199610
199820
FIG. 1 — Lineage of K994106, 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 ITX? 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 ITX device

  1. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (4)

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
*K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use
Summary page 2
…e Classification Name: 21 CFR892.1570 Diagnostic Ultrasonic transducer K 994106 p. 2 o3 Predicate Device: MODEL NAME S510(k)y# UM-2R Ultrasonic Probe K982323 UM-3R Ultrasonic Probe K982323 EU-M30 Endoscopic Ultrasound K982610(for urinary), Center K951994(for gastrointestinal tract),…
Olympus America, Inc.1998—
*K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)
Summary page 2
…r K 994106 p. 2 o3 Predicate Device: MODEL NAME S510(k)y# UM-2R Ultrasonic Probe K982323 UM-3R Ultrasonic Probe K982323 EU-M30 Endoscopic Ultrasound K982610(for urinary), Center K951994(for gastrointestinal tract), K982323(for bronchial use) MH-240 Probe Driving Unit K982610(for uri…
Olympus Optical, Co.1998—
*K951994Olympus EU-M30 Endoscopic Ultrasound Center
Summary page 2
…2 o3 Predicate Device: MODEL NAME S510(k)y# UM-2R Ultrasonic Probe K982323 UM-3R Ultrasonic Probe K982323 EU-M30 Endoscopic Ultrasound K982610(for urinary), Center K951994(for gastrointestinal tract), K982323(for bronchial use) MH-240 Probe Driving Unit K982610(for urinary), K951994(for gastrointes…
Olympus America, Inc.1996—
*K982733Olympus MH-246R Balloon Sheath, for Bronchial Use
Summary page 2
…), K982323(for bronchial use) MH-240 Probe Driving Unit K982610(for urinary), K951994(for gastrointestinal tract), K982323(for bronchial use) MH-246R | Balloon Sheath K982733 (for UM-2R/3R) D. Description of the Device(s) The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Oly…
The Olympus Optical Co.1998—

Also cleared against K982323: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K982323.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

What is it indicated for?

The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K982323

7 other devices cite the same predicate.

  • K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)Boston Scientific Corporation · 2023
  • K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation · 2007
  • K042438Superdimension/BronchusSuperdimension, Ltd. · 20041 recall
  • K021204Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
  • K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM…Olympus America, Inc. · 20011 recall
  • K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 20012 recalls

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 ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K994106 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994106: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994106

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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