510(k) · Cleared
ClearedOlympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Dec 11, 1998 as substantially equivalent to K951994 (Olympus America, Inc., 1996) and 3 other predicates after a 162-day review. Its family tree reaches back 2 generations to 1993. 6 of the 147 devices in its family, counting itself, have a Class I recall. 142 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 162 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K926514 (1993). 4 ancestors in all, the oldest K882061 (1988). 142 later devices descend from it, 8 citing it directly. 6 of the 147 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 1 generation backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- This deviceK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- Descendant · cites it directly · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
- Descendant · cites it directly · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
- Descendant · 2 generations on · 56 of its ownK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- Descendant · 3 generations on · 55 of its ownK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 142 · See all- K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · cites it directly73descendants
- 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 · cites it directly59descendants
- K052260Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · 2 generations on56descendants
- K052852Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · 3 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −1 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| 0 (this device) | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| +1 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| +1 | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | 1 |
| +1 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
| +2 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| +3 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 11 | 0 |
| 2013 | 1 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 1 |
| 2020 | 7 | 1 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 1 |
| 2024 | 5 | 2 |
| 2025 | 13 | 1 |
| 2026 | 6 | 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.
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 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951994 | Olympus EU-M30 Endoscopic Ultrasound CenterSummary page 1…ion Number Class II, 21 CFR 892.1570 and Name: Diagnostic Ultrasound Transducer Class I 21 CFR 874.4680 Bronchoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R/3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted by: Laura Storms-Tyler Olympus America In… | 1996 |
| * | K944610 | Olympus Ultrasonic ProbesSummary page 1…892.1570 and Name: Diagnostic Ultrasound Transducer Class I 21 CFR 874.4680 Bronchoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R/3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted by: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Dri… | 1995 |
| * | K926514 | Endoscopic Ultrasound System Type 20Summary page 1…nostic Ultrasound Transducer Class I 21 CFR 874.4680 Bronchoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R/3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted by: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, NY 11042-117… | 1993 |
| * | K882061 | Olympus GF-UM3/EU-M3Summary page 1…ucer Class I 21 CFR 874.4680 Bronchoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R/3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted by: Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, NY 11042-1179 (516) 844-5688 Summar… | 1988 |
What descends from it? (142)
See all 1428 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042438 | Superdimension/Bronchus | 2004 | 73 |
| K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | 2001 | 60 |
| K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | 2001 | 59 |
| K021204 | Olympus BF Type UM40 | 2002 | 44 |
| K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope | 2007 | 15 |
| K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | 2000 | 3 |
| K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console… | 2023 | 0 |
| K994106 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use | 2000 | 0 |
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 · 6 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 · 11 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 · 12 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 · 12 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 · 12 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 12 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K042438 (Superdimension, Ltd., 2004) has gone furthest, with 73 descendants of its own.
- 6 other devices also cite its predicate K951994.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
Olympus UM-2R and UM-3R Ultrasonic Probes have been designed for use in
conjunction with 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.
https://510kreport.com/device/K982323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982323
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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