510(k) · Cleared
ClearedEndoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Dec 13, 2023 as substantially equivalent to K994103 (Olympus America, Inc., 2000) after a 189-day review. Its family tree reaches back 4 generations to 1993. 2 later devices descend from it.
- Decided
- Dec 13, 2023
- Review
- 189 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K926514 (1993). 7 ancestors in all, the oldest K882061 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 3 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 2 generations backK982610 Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary…Olympus Optical, Co. · 1998
- 1 generation backK994103 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
- This deviceK231666 Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe…FUJIFILM Healthcare Americas Corporation · 2023
- Descendant · cites it directly · 0 of its ownK250883 Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R…Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK250762 Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe…Olympus Medical Systems Corporation · 2025
Most influential descendants
Showing 2 of 2 · See all- K250883Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K250762Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −3 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −2 | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary… | Olympus Optical, Co. | 1998 | — |
| −1 | K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | Olympus America, Inc. | 2000 | — |
| 0 (this device) | K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| +1 | K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R… | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Summary page 4…Review Panel Predicate Device: • OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT (K994103) Reference Device: • Modifications to EUB-525 Diagnostic Ultrasound Scanner; EUB-2000 Diagnostic Ultrasound Scanner;… | 2000 |
| † | K012239 | Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound… | 2001 |
What descends from it? (2)
2 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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K250883 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 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. 2023, this device’s year, is highlighted.
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?
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.
Modes of Operation: B-mode
Never use this product for any other purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231666: Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231666
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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