510(k) Report

510(k) · Cleared

Cleared

Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract

K001203510(k) TraditionalCleared May 26, 200043-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

The Olympus Optical Co. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on May 26, 2000 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 62 devices in its family, counting itself, has a Class I recall. 61 later devices descend from it.

Decided
May 26, 2000
Review
43 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
0

61 later devices descend from it, 1 citing it directly. 1 of the 62 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2007: 2 descendants cleared2004: 2 descendants cleared2009: 2 descendants cleared2012: 4 descendants cleared2005: 1 descendant cleared2013: 1 descendant cleared2020: 4 descendants cleared, 1 with a Class I recall12023: 4 descendants cleared2015: 3 descendants cleared2016: 5 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2019: 6 descendants cleared2014: 3 descendants cleared2025: 6 descendants cleared2018: 4 descendants cleared2017: 3 descendants cleared2022: 2 descendants cleared2026: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK001203 Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment…The Olympus Optical Co. · 2000
  2. Descendant · cites it directly · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 44 of its ownK021204 Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
  4. Descendant · 3 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
  5. Descendant · 4 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
  6. Descendant · 2 generations on · 16 of its ownK043275 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12004: 22005: 12007: 22008: 12009: 22010: 12012: 42013: 12014: 32015: 32016: 52017: 32018: 42019: 62020: 42021: 12022: 22023: 42024: 12025: 62026: 3
2001high 6 (2019) · low 0 (2003)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX7 generations on · 2020

Most influential descendants

Showing 5 of 61 · See all
  • K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · cites it directly60descendants
  • K021204Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002 · 2 generations on44descendants
  • K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 3 generations on43descendants
  • K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 4 generations on28descendants
  • K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001203Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for…The Olympus Optical Co.2000—
+1K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.20011
+2K021204Olympus BF Type UM40Olympus Optical Co., Ltd.2002—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation20041
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation20055
+2K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200420
200510
200720
200810
200920
201010
201240
201310
201430
201530
201650
201730
201840
201960
202041
202110
202220
202340
202410
202560
202630
FIG. 1 — Lineage of K001203, 2000–2026Source: 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.

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 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? (61)

See all 61

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.200160

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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K011886 (Olympus America, Inc., 2001) has gone furthest, with 60 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 The Olympus Optical Co.

22 FDA decisions under this applicant name. See the company

  • K032066Sonosurg SystemThe Olympus Optical Co. · 2003
  • K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 20033 recalls
  • K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
  • K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 200314 Class I recalls
  • K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 20021 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/K001203 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001203: Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001203

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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