510(k) · Cleared
ClearedCozumel Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 8, 1998 after a 14-day review. The FDA summary names its predicate without a number. 3 of the 234 devices in its family, counting itself, have a Class I recall. 233 later devices descend from it.
- Decided
- May 8, 1998
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
233 later devices descend from it, 2 citing it directly. 3 of the 234 devices in this family, counting this one, have a Class I recall.
- This deviceK981505 Cozumel Diagnostic Ultrasound SystemSonosite,Inc. · 1998
- Descendant · cites it directly · 232 of its ownK990806 C1 Ultrasound SystemSonosite,Inc. · 1999
- Descendant · cites it directly · 196 of its ownK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- Descendant · 2 generations on · 135 of its ownK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
- Descendant · 3 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
Showing 5 of 233 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 233 · See all- K990806C1 Ultrasound SystemSonosite,Inc. · 1999 · cites it directly232descendants
- K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999 · cites it directly196descendants
- K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on135descendants
- K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · 3 generations on130descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 3 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981505 | Cozumel Diagnostic Ultrasound System | Sonosite,Inc. | 1998 | — |
| +1 | K990806 | C1 Ultrasound System | Sonosite,Inc. | 1999 | — |
| +1 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| +2 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K092756 | GE Vscan Compact Diagnostic Ultrasound System | Ge Vingmed Ultrasound AS | 2009 | — |
| +3 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 8 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 13 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 22 | 1 |
| 2021 | 16 | 0 |
| 2022 | 14 | 0 |
| 2023 | 15 | 0 |
| 2024 | 13 | 0 |
| 2025 | 26 | 2 |
| 2026 | 21 | 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.
3 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | — | Atl Hdi® 5000 Named without a submission number | |
| * | — | Medison SA600 diagnostic ultrasound systems Named without a submission number | |
| * | — | ATL Ultramark® 4 system Named without a submission number |
What descends from it? (233)
See all 2332 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K990806 (Sonosite,Inc., 1999) has gone furthest, with 232 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
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:
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/K981505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981505: Cozumel Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981505
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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