510(k) · Cleared
ClearedHdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atl Ultrasound, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Mar 24, 2000 as substantially equivalent to K961459 (Advanced Technology Laboratories, Inc., 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1993. 27 later devices descend from it.
- Decided
- Mar 24, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926514 (1993). 3 ancestors in all. 27 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 1 generation backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- This deviceK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- Descendant · cites it directly · 24 of its ownK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- Descendant · 2 generations on · 13 of its ownK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- Descendant · 3 generations on · 12 of its ownK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- Descendant · 4 generations on · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- Descendant · 5 generations on · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003 · cites it directly24descendants
- K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003 · 2 generations on13descendants
- K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005 · 3 generations on12descendants
- K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · 4 generations on9descendants
- K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · 5 generations on8descendants
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 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| 0 (this device) | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| +1 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| +2 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| +3 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| +4 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| +5 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961459 | Level 10 HdiSummary page 1…ead to be used with the HDI 1500/SA 8800 Ultrasound system is substantially equivalent to the currently marketed MPT7-4 transducer marketed with the ATL HDI 5000 System, K961459, and the Olympus Ultrasonic Endoscope (K963023). Device Description: The HDI 1500/SA 8800 system is a general purpose, mobile,… | 1997 |
| * | K963023 | Ultrasound Gastroscope GF Type UM30PSummary page 1…ound system is substantially equivalent to the currently marketed MPT7-4 transducer marketed with the ATL HDI 5000 System, K961459, and the Olympus Ultrasonic Endoscope (K963023). Device Description: The HDI 1500/SA 8800 system is a general purpose, mobile, software controlled, diagnostic ultrasound syst… | 1997 |
What descends from it? (27)
See all 272 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 7 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K030191 (Teratech Corp., 2003) has gone furthest, with 24 descendants of its own.
- 15 other devices also cite its predicate K961459.
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 or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or 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/K994373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994373: Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994373
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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