510(k) · Cleared
Recalled · Class III · 2025Sonos 5500 Imaging System M2424A Version B.O
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 18, 1999 as substantially equivalent to K972348 (Hewlett-Packard Co., 1997) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1994. 189 later devices descend from it. It has been recalled once.
- Decided
- Feb 18, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K935009 (1994). 9 ancestors in all. 189 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK935009 PegasusAdvanced Technology Laboratories, Inc. · 1994
- 2 generations backK954028 HP Sonos Ultrasound Imaging SystemHewlett-Packard Co. · 1996 · Recalled
- 1 generation backK972348 HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co. · 1997 · Recalled
- This deviceK990339 Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co. · 1999
- Descendant · cites it directly · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 179 of its ownK083001 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 178 of its ownK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 189 · See all- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly188descendants
- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on182descendants
- K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on180descendants
- K083001M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on179descendants
- K083505DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935009 | Pegasus | Advanced Technology Laboratories, Inc. | 1994 | — |
| −2 | K954028 | HP Sonos Ultrasound Imaging System | Hewlett-Packard Co. | 1996 | 2 |
| −1 | K972348 | HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System | Hewlett-Packard Co. | 1997 | 1 |
| 0 (this device) | K990339 | Sonos 5500 Imaging System M2424A Version B.O | Hewlett-Packard Co. | 1999 | — |
| +1 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K083001 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K083505 | DC-3/DC-3T 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 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K972348 | HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemSummary page 1…trasound Transducer. 3. The modification involves expanded indications for use on the M2424A system to allow endocavity imaging using HP’s endocavity transducer 21336A (K972348). Additionally, a new intraoperative transducer (21390A) that has new patient contact materials, is being added to the M2424A sys… | 1997 |
| * | K971116 | Sonos 5500 Imaging SystemSummary page 1…endocavity applications on the M2410A (K972348). The 21390A has the same intended use as its predicate device 213802 cleared for intraoperative use on the M2424A system (K971116). The 21330A has the same intended use as Acuson Corporation’s 3V2c 003 - transducer on its Sequoia Ultrasound S… | 1998 |
| * | K973767 | Harmonic Imaging with ContrastSummary page 2…use on the M2424A system (K971116). The 21330A has the same intended use as Acuson Corporation’s 3V2c 003 - transducer on its Sequoia Ultrasound System (K973767) with respect to abdominal and adult cephalic applications. 6. The modifications to the M2424A system and its probes result in n… | 1997 |
What descends from it? (189)
See all 1891 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072164 | DC-6 Diagnostic Ultrasound System | 2007 | 188 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K072164 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 188 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows:
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows:
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/K990339 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990339: Sonos 5500 Imaging System M2424A Version B.O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990339
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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