510(k) · Cleared
ClearedDermascan C, an Ultrasonic Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brymill Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 2, 1989 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Oct 2, 1989
- Review
- 63 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK894834 Dermascan C, an Ultrasonic Diagnostic SystemBrymill Corp. · 1989
- Descendant · cites it directly · 17 of its ownK983945 Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999
- Descendant · 2 generations on · 16 of its ownK132028 Ulthera SystemUlthera, Inc. · 2013
- Descendant · 3 generations on · 15 of its ownK134032 Ulthera SystemUlthera, Inc. · 2014
- Descendant · 4 generations on · 13 of its ownK180623 Ulthera SystemUlthera, Inc. · 2018
- Descendant · 5 generations on · 8 of its ownK211483 SofWave SystemSofwave Medical, Ltd. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K983945Cortex Dermascan C Ultrasonic SystemCortex Technology Aps · 1999 · cites it directly17descendants
- K132028Ulthera SystemUlthera, Inc. · 2013 · 2 generations on16descendants
- K134032Ulthera SystemUlthera, Inc. · 2014 · 3 generations on15descendants
- K180623Ulthera SystemUlthera, Inc. · 2018 · 4 generations on13descendants
- K211483SofWave SystemSofwave Medical, Ltd. · 2021 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894834 | Dermascan C, an Ultrasonic Diagnostic System | Brymill Corp. | 1989 | — |
| +1 | K983945 | Cortex Dermascan C Ultrasonic System | Cortex Technology Aps | 1999 | — |
| +2 | K132028 | Ulthera System | Ulthera, Inc. | 2013 | — |
| +3 | K134032 | Ulthera System | Ulthera, Inc. | 2014 | — |
| +4 | K180623 | Ulthera System | Ulthera, Inc. | 2018 | — |
| +5 | K211483 | SofWave System | Sofwave Medical, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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.
Planning a device in IYO? 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? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K983945 (Cortex Technology Aps, 1999) has gone furthest, with 17 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/K894834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894834: Dermascan C, an Ultrasonic Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894834
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026