510(k) · Cleared
ClearedSonos 5500 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 Jan 12, 1998 as substantially equivalent to K944048 (Hewlett-Packard Co., 1995) after a 292-day review. Its family tree reaches back 1 generation to 1995. 190 later devices descend from it.
- Decided
- Jan 12, 1998
- Review
- 292 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944048 (1995). 190 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944048 Ultrasound 77030 Imaging SystemHewlett-Packard Co. · 1995
- This deviceK971116 Sonos 5500 Imaging SystemHewlett-Packard Co. · 1998
- 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 |
|---|---|---|---|---|---|
| −1 | K944048 | Ultrasound 77030 Imaging System | Hewlett-Packard Co. | 1995 | — |
| 0 (this device) | K971116 | Sonos 5500 Imaging System | Hewlett-Packard Co. | 1998 | — |
| +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 | — |
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? (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 |
|---|---|---|---|
| * | K944048 | Ultrasound 77030 Imaging SystemSummary page 1…The predicate device for this submittal is the existing Intra-Operative transducer (21275A) which was reviewed by FDA on the 77030A system that was submitted as part of K944048. 4) Description of the device or modification being submitted for premarket approval. Functionality: The new transducer has equ… | 1995 |
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)
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, K990339 (Hewlett-Packard Co., 1999) has gone furthest, with 189 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 of the human body in the applications detailed below.
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/K971116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971116: Sonos 5500 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/K971116
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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