510(k) · Cleared
ClearedLiquiband Ultima, Model LB0004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medlogic Global, Ltd. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Feb 12, 2009 as substantially equivalent to P010002 (Covidien Lp, Formerly Registered AS United States, 2002) after a 76-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.
- Decided
- Feb 12, 2009
- Review
- 76 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P010002 (2002). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
- This deviceK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
- Descendant · cites it directly · 6 of its ownK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
- Descendant · 2 generations on · 5 of its ownK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100284Liquiband Ultima, Lut 003Medlogic Global Limited · 2010 · cites it directly9descendants
- K110184Liquiband Flow ControlMedlogic Global Limited · 2011 · cites it directly6descendants
- K122446Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · 2 generations on5descendants
- K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · 2 generations on3descendants
- K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P010002 | Indermil (TM) Tissue Adhesive | Covidien Lp, Formerly Registered AS United States | 2002 | — |
| 0 (this device) | K083531 | Liquiband Ultima, Model LB0004 | Medlogic Global, Ltd. | 2009 | — |
| +1 | K100284 | Liquiband Ultima, Lut 003 | Medlogic Global Limited | 2010 | — |
| +1 | K110184 | Liquiband Flow Control | Medlogic Global Limited | 2011 | — |
| +2 | K122446 | Liquidband Flow Control | Advanced Medical Solutions (Plymouth), Ltd. | 2012 | 1 |
| +2 | K123133 | Barle Tissue Adhesive | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | — |
| +3 | K132243 | Barle Tissue Adhesive 2 | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | P010002 | Indermil (TM) Tissue AdhesiveSummary page 1…Topical Skin Adhesive Classification Name: Tissue Adhesive (21 CFR 878.4010) Predicate Device(s): Indermil® Tissue Adhesive (P010002) Device Description: LiquiBand Topical Skin Adhesive is a sterile, topical tissue… | 2002 |
What descends from it? (10)
2 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?
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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083531: Liquiband Ultima, Model LB0004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083531
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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