510(k) · Cleared
ClearedPLUS 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dymax Corp · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 15, 1985 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 277 devices in its family, counting itself, have a Class I recall. 276 later devices descend from it.
- Decided
- Apr 15, 1985
- Review
- 63 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
276 later devices descend from it, 1 citing it directly. 2 of the 277 devices in this family, counting this one, have a Class I recall.
- This deviceK850478 PLUS 1Dymax Corp · 1985
- Descendant · cites it directly · 275 of its ownK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- Descendant · 2 generations on · 140 of its ownK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- Descendant · 3 generations on · 139 of its ownK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- Descendant · 4 generations on · 136 of its ownK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- Descendant · 2 generations on · 124 of its ownK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
Showing 5 of 276 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 276 · See all- K993624Site-Rite 3 Ultrasound SystemDymax Corp · 1999 · cites it directly275descendants
- K032135Site-Rite IV Ultrasound SystemDymax Corp · 2003 · 2 generations on140descendants
- K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005 · 3 generations on139descendants
- K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007 · 4 generations on136descendants
- K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002 · 2 generations on124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| +1 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| +2 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| +3 | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| +4 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| +2 | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | Sonosite,Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 12 | 0 |
| 2020 | 27 | 0 |
| 2021 | 23 | 0 |
| 2022 | 24 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 30 | 2 |
| 2026 | 26 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (276)
See all 2761 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993624 | Site-Rite 3 Ultrasound System | 1999 | 275 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- Of its descendants, K993624 (Dymax Corp, 1999) has gone furthest, with 275 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 | — |
https://510kreport.com/device/K850478 · printed Nov 3, 2026
Cite this page
510(k) Report. “K850478: PLUS 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K850478
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026