510(k) · Cleared
ClearedEup-OL334 Laparascopicprobe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Corp. of America · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 27, 1998 as substantially equivalent to K954220 (Hitachi Medical Corp. of America, 1997) after a 97-day review. Its family tree reaches back 1 generation to 1997. 12 later devices descend from it.
- Decided
- Jul 27, 1998
- Review
- 97 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954220 (1997). 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954220 EUB-8000Hitachi Medical Corp. of America · 1997
- This deviceK981434 Eup-OL334 LaparascopicprobeHitachi Medical Corp. of America · 1998
- Descendant · cites it directly · 9 of its ownK013640 EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002
- Descendant · 2 generations on · 8 of its ownK063847 Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR…Fujinon, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK111243 Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK120446 Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 3 of its ownK181763 FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp. · 2002 · cites it directly9descendants
- K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc. · 2007 · 2 generations on8descendants
- K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011 · 3 generations on7descendants
- K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 2012 · 3 generations on4descendants
- K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954220 | EUB-8000 | Hitachi Medical Corp. of America | 1997 | — |
| 0 (this device) | K981434 | Eup-OL334 Laparascopicprobe | Hitachi Medical Corp. of America | 1998 | — |
| +1 | K013640 | EG-3630UR, Ultrasund Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| +2 | K063847 | Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 | Fujinon, Inc. | 2007 | 1 |
| +3 | K111243 | Fujinon Ultrasonic Processor | Fujinon, Inc. | 2011 | — |
| +3 | K120446 | Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 | Fujinon, Inc. | 2012 | 1 |
| +4 | K181763 | FUJIFILM Ultrasonic Endoscope | Fujifilm Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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.
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 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K926208 | Unnamed device Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6…card.) | P | P r 14 E Other (spec.) Peripheral |JPeripheral vessel P|P P p E - Vessel Other (spec.) N= new indications for EUP-OL334; P= previously cleared by FDA under K926208; E= added under Appendix I of the Feb. 17, 1993 guidance. * Amphtude D0ppler Addxtxonal Comments Concurrénce o (Division Sign-… | |
| * | K954220 | EUB-8000Summary page 7…(card.) J P | P P P P Other (spec.) Peripheral JPeripheral vessel PP p p P P Vessel Other (spec.) N= new indications for EUP-OL334; P= previously cleared by FDA under K954220. * Amplitude Doppler Additional Comments: “Pa”; i Concurrence of CDRH Office of Device Evaluatmn (ODE) (Division ngn Off) LN Div… | 1997 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K013640 (Pentax Precision Instrument Corp., 2002) has gone furthest, with 9 descendants of its own.
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?
Diagnostic ultrasound imaging and fluid flow analysis of the human body as follows:
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/K981434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981434: Eup-OL334 Laparascopicprobe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981434
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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