PMA · Approved
ApprovedIndermil (TM) Tissue Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS United States · MPN Tissue Adhesive For The Topical Approximation Of Skin
Approved on May 22, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 475-day review. 14 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 475 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
14 later devices descend from it, 4 citing it directly.
- This deviceP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
- Descendant · cites it directly · 10 of its ownK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
- Descendant · 2 generations on · 9 of its ownK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
- Descendant · 2 generations on · 6 of its ownK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
- Descendant · 3 generations on · 5 of its ownK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K083531Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009 · cites it directly10descendants
- K100284Liquiband Ultima, Lut 003Medlogic Global Limited · 2010 · 2 generations on9descendants
- K110184Liquiband Flow ControlMedlogic Global Limited · 2011 · 2 generations on6descendants
- K122446Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · 3 generations on5descendants
- K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P010002 | Indermil (TM) Tissue Adhesive | Covidien Lp, Formerly Registered AS United States | 2002 | — |
| +1 | K083531 | Liquiband Ultima, Model LB0004 | Medlogic Global, Ltd. | 2009 | — |
| +2 | K100284 | Liquiband Ultima, Lut 003 | Medlogic Global Limited | 2010 | — |
| +2 | K110184 | Liquiband Flow Control | Medlogic Global Limited | 2011 | — |
| +3 | K122446 | Liquidband Flow Control | Advanced Medical Solutions (Plymouth), Ltd. | 2012 | 1 |
| +3 | K123133 | Barle Tissue Adhesive | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MPN? 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 MPN device
- #1 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (14)
See all 144 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, K083531 (Medlogic Global, Ltd., 2009) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MPN devicesMPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPN
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPN
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPN
244in 2025
MAUDE reports naming product code MPN, 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 | 1 | — | 0 | 56 |
| 2008 | 1 | — | 0 | 32 |
| 2009 | 1 | — | 0 | 22 |
| 2010 | 3 | 77 | 0 | 21 |
| 2011 | 2 | — | 0 | 93 |
| 2012 | 2 | — | 0 | 135 |
| 2013 | 6 | 193 | 0 | 177 |
| 2014 | 4 | 96 | 0 | 199 |
| 2015 | 4 | 141 | 0 | 179 |
| 2016 | 5 | 173 | 0 | 194 |
| 2017 | 0 | — | 0 | 182 |
| 2018 | 0 | — | 0 | 272 |
| 2019 | 0 | — | 0 | 427 |
| 2020 | 2 | — | 0 | 225 |
| 2021 | 1 | — | 1 | 141 |
| 2022 | 0 | — | 0 | 165 |
| 2023 | 0 | — | 0 | 130 |
| 2024 | 3 | 266 | 0 | 236 |
| 2025 | 2 | — | 0 | 244 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P010002 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010002: Indermil (TM) Tissue Adhesive.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010002
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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