510(k) · Cleared
ClearedMesoderm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aa Advanced Technology, Inc. · EGJ Device, Iontophoresis, Other Uses
Cleared on Apr 30, 2007 as substantially equivalent to K032968 (Mattioli Engineering Corp., 2003) and 1 other predicate after a 304-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Apr 30, 2007
- Review
- 304 days
- Class
- Class II
- Product code
- EGJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863166 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK863166 Model 6110 Iontophoretic ApplicatorLife-Tech Intl., Inc. · 1987
- 2 generations backK032968 Trsansderm Ionto SystemMattioli Engineering Corp. · 2003
- 1 generation backK042590 Transderm Ionto System, MK 2Mattioli Engineering Corp. · 2004
- This deviceK061849 MesodermAa Advanced Technology, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK083016 ActhydermMicrolab Americas, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083016ActhydermMicrolab Americas, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863166 | Model 6110 Iontophoretic Applicator | Life-Tech Intl., Inc. | 1987 | — |
| −2 | K032968 | Trsansderm Ionto System | Mattioli Engineering Corp. | 2003 | — |
| −1 | K042590 | Transderm Ionto System, MK 2 | Mattioli Engineering Corp. | 2004 | — |
| 0 (this device) | K061849 | Mesoderm | Aa Advanced Technology, Inc. | 2007 | — |
| +1 | K083016 | Acthyderm | Microlab Americas, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 EGJ? 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 EGJ device
- #1 K242041 STOPWET iontophoresis apparatus (SW01)score 9.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032968 | Trsansderm Ionto SystemSummary page 1…EGJ Classification Name: Device, Iontophoresis, Specific Uses Codes of Federal Regulations: 21 CFR 890.5525 Predicate Device: K032968 & K042590 Transderm® System, Transderm Ionto System Device Description: MesoDerm is a device that is a microprocessor controlle… | 2003 |
| * | K042590 | Transderm Ionto System, MK 2Summary page 1…EGJ Classification Name: Device, Iontophoresis, Specific Uses Codes of Federal Regulations: 21 CFR 890.5525 Predicate Device: K032968 & K042590 Transderm® System, Transderm Ionto System Device Description: MesoDerm is a device that is a microprocessor controlled iontopho… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083016 | Acthyderm | 2009 | 0 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083016 (Microlab Americas, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032968.
How does its category compare?
All EGJ devicesEGJ Device, Iontophoresis, Other Uses: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EGJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGJ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGJ
3in 2025
MAUDE reports naming product code EGJ, 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 | 5 | 104 | 0 | 1 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 21 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MesoDerm is indicated for the administration of soluble salts or other drugs into the body for medical purposes as an alternative to hypodermic injections.
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/K061849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061849: Mesoderm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061849
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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