510(k) · Cleared
Recalled · Class III · 2025HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound 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 Jul 24, 1997 as substantially equivalent to K935923 (Hewlett-Packard Co., 1994) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1994. 190 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935009 (1994). 4 ancestors in all. 190 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK935009 PegasusAdvanced Technology Laboratories, Inc. · 1994
- 1 generation backK954028 HP Sonos Ultrasound Imaging SystemHewlett-Packard Co. · 1996 · Recalled
- This deviceK972348 HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co. · 1997
- Descendant · cites it directly · 189 of its ownK990339 Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co. · 1999 · Recalled
- Descendant · 2 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 3 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 3 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 3 generations on · 179 of its ownK083001 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 190 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 190 · See all- K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co. · 1999 · cites it directly189descendants
- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on188descendants
- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on182descendants
- K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on180descendants
- K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on179descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935009 | Pegasus | Advanced Technology Laboratories, Inc. | 1994 | — |
| −1 | K954028 | HP Sonos Ultrasound Imaging System | Hewlett-Packard Co. | 1996 | 2 |
| 0 (this device) | K972348 | HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System | Hewlett-Packard Co. | 1997 | — |
| +1 | K990339 | Sonos 5500 Imaging System M2424A Version B.O | Hewlett-Packard Co. | 1999 | 1 |
| +2 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +3 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +3 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +3 | K083001 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 6 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2015 | 17 | 0 |
| 2016 | 10 | 0 |
| 2017 | 25 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 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.
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 |
|---|---|---|---|
| * | K935923 | Philips Ultrasound P800 Imaging SystemSummary page 1…odes: 90-ITX, 90-IYO, and 90-IYN Identification of Predicate Devices: 21370A endovaginal probe and 21371 A endorectal probes used on HP-Philips SD800 ultrasound system (K935923) and HP M2410A ultrasound system (K954028) Description of the device or modification being submitted for premarket approval. Fu… | 1994 |
| * | K954028 | HP Sonos Ultrasound Imaging SystemSummary page 1…cation of Predicate Devices: 21370A endovaginal probe and 21371 A endorectal probes used on HP-Philips SD800 ultrasound system (K935923) and HP M2410A ultrasound system (K954028) Description of the device or modification being submitted for premarket approval. Functionality: 21336A EV/ER probe has equiva… | 1996 |
What descends from it? (190)
See all 1901 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990339 | Sonos 5500 Imaging System M2424A Version B.O | 1999 | 189 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2025 | Class III | Z-2348-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K990339 (Hewlett-Packard Co., 1999) has gone furthest, with 189 descendants of its own.
- 3 other devices also cite its predicate K935923.
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 Doppler analysis of the human body as follows:
Other Indications or Modes: combined_modes are: B+M. B+PW
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/K972348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972348: HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972348
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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