510(k) Report

510(k) · Cleared

Cleared

Olympus Ultrasonic Probes

K944610510(k) TraditionalCleared Apr 10, 1995203-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 Apr 10, 1995 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 147 devices in its family, counting itself, have a Class I recall. 146 later devices descend from it.

Decided
Apr 10, 1995
Review
203 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
0

146 later devices descend from it, 6 citing it directly. 6 of the 147 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 2 descendants cleared2023: 9 descendants cleared, 1 with a Class I recall12007: 3 descendants cleared2000: 3 descendants cleared2001: 2 descendants cleared2002: 1 descendant cleared2004: 3 descendants cleared2009: 10 descendants cleared2012: 11 descendants cleared2003: 1 descendant cleared2006: 2 descendants cleared2008: 5 descendants cleared2005: 4 descendants cleared2013: 1 descendant cleared2020: 7 descendants cleared, 1 with a Class I recall12025: 13 descendants cleared, 1 with a Class I recall12011: 4 descendants cleared2014: 10 descendants cleared2010: 4 descendants cleared2026: 6 descendants cleared2016: 7 descendants cleared2018: 7 descendants cleared2015: 6 descendants cleared2019: 10 descendants cleared, 1 with a Class I recall12017: 5 descendants cleared2022: 2 descendants cleared2021: 3 descendants cleared2024: 5 descendants cleared, 2 with a Class I recall21995200020052010201520202025
  1. This deviceK944610 Olympus Ultrasonic ProbesOlympus America, Inc. · 1995
  2. Descendant · cites it directly · 142 of its ownK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
  3. Descendant · 2 generations on · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
  4. Descendant · cites it directly · 67 of its ownK982610 Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary…Olympus Optical, Co. · 1998
  5. Descendant · cites it directly · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
  6. Descendant · 2 generations on · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled

Showing 5 of 146 descendants. See all descendants

Descendants cleared per year

1998: 22000: 32001: 22002: 12003: 12004: 32005: 42006: 22007: 32008: 52009: 102010: 42011: 42012: 112013: 12014: 102015: 62016: 72017: 52018: 72019: 102020: 72021: 32022: 22023: 92024: 52025: 132026: 6
1998high 13 (2025) · low 0 (1999)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX7 generations on · 2020
  • K190106 Intra-Operative Positioning System; Simple Curve…12 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…13 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…13 generations on · 2024

Most influential descendants

Showing 5 of 146 · See all
  • K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc. · 1998 · cites it directly142descendants
  • K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · 2 generations on73descendants
  • K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co. · 1998 · cites it directly67descendants
  • K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · cites it directly60descendants
  • K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · 2 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944610Olympus Ultrasonic ProbesOlympus America, Inc.1995—
+1K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for…Olympus America, Inc.1998—
+2K042438Superdimension/BronchusSuperdimension, Ltd.20041
+1K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary…Olympus Optical, Co.1998—
+1K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.20011
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.20012

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200030
200120
200210
200310
200430
200540
200620
200730
200850
2009100
201040
201140
2012110
201310
2014100
201560
201670
201750
201870
2019101
202071
202130
202220
202391
202452
2025131
202660
FIG. 1 — Lineage of K944610, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

6 devices in this family have 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 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (146)

See all 146

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

NumberDeviceApplicantDecidedDescendants
K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc.1998142
K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co.199867
K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.200160
K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation200715
K994103Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.20003
K231889Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic…Ultrasound Biotechnology (Shanghai) Co., Ltd.20230

Has anything in its family been recalled? (6 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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 12 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 13 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • Of its descendants, K982323 (Olympus America, Inc., 1998) has gone furthest, with 142 descendants of its own.

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—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

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  • 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/K944610 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944610: Olympus Ultrasonic Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944610

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026