510(k) · Cleared
ClearedLinear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 24, 1999 as substantially equivalent to K954028 (Hewlett-Packard Co., 1996) and 3 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Feb 24, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K934041 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 2 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 1 generation backK980687 Sonos 5500 Ultrasound Imaging SystemHewlett-Packard Co. · 1998
- This deviceK990400 Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging…Hewlett-Packard Co. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −2 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −1 | K980687 | Sonos 5500 Ultrasound Imaging System | Hewlett-Packard Co. | 1998 | — |
| 0 (this device) | K990400 | Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System | Hewlett-Packard Co. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K954028 | HP Sonos Ultrasound Imaging System Our OCR of the scanned summary read K954023, FDA’s number for Osteonics Secur-Fit HA PSL Extra Acetabular Component System (Osteonics Corp.). Corrected to the only number one digit away that is an earlier device of this one’s maker, Hewlett-Packard Co., in this field. | 1996 |
| * | K964309 | Sonos 2000, Sonos 2500 (M2406 a)Summary page 1…magePoint system, with new platform modes, new indications for use, and new transducer, functions in the same way as its predicate devices, the M2410A 'K954023), M2424A (K964309 and K380687) and the Acuson Aspen System, witn L7 probe, (K373079) by allowing ultrasound imaging of the humar =znatomy. 5. The… | 1997 |
| * | K980687 | Sonos 5500 Ultrasound Imaging System Our OCR of the scanned summary read K380687, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Hewlett-Packard Co., in this field. | 1998 |
| * | K973079 | L7 Transducer Used on Aspen Model Ultrasound System Our OCR of the scanned summary read K373079, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acuson Aspen System with L7 probe”. | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K954028.
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 Doppler 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/K990400 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990400: Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990400
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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