510(k) · Cleared
ClearedBarle Tissue Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Solutions (Plymouth), Ltd. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on May 22, 2013 as substantially equivalent to K100284 (Medlogic Global Limited, 2010) and 4 other predicates after a 230-day review. Its family tree reaches back 3 generations to 2002. 3 later devices descend from it.
- Decided
- May 22, 2013
- Review
- 230 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to P010002 (2002). 7 ancestors in all, the oldest P960052 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
- 2 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
- 1 generation backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
- This deviceK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK151182 LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK183570 LiquiBand PlusAdvanced Medical Solutions Limited · 2020
Most influential descendants
Showing 3 of 3 · See all- K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly2descendants
- K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd. · 2015 · 2 generations on1descendant
- K183570LiquiBand PlusAdvanced Medical Solutions Limited · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P010002 | Indermil (TM) Tissue Adhesive | Covidien Lp, Formerly Registered AS United States | 2002 | — |
| −2 | K083531 | Liquiband Ultima, Model LB0004 | Medlogic Global, Ltd. | 2009 | — |
| −1 | K100284 | Liquiband Ultima, Lut 003 | Medlogic Global Limited | 2010 | — |
| 0 (this device) | K123133 | Barle Tissue Adhesive | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | — |
| +1 | K132243 | Barle Tissue Adhesive 2 | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | 1 |
| +2 | K151182 | LiquiBand Exceed | Advanced Medical Solutions (Plymouth), Ltd. | 2015 | — |
| +3 | K183570 | LiquiBand Plus | Advanced Medical Solutions Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K100284 | Liquiband Ultima, Lut 003Summary page 3…of action and performance at achieving its intended use and LiquiBand Ultima Topical Skin Adhesive (K1 00284) with regard to Indication For Use, applicator technology, target population,… | 2010 |
| * | K100423 | Dermabond NX Adhesive Model: DNX6, DNX12Summary page 1…Tissue Adhesive (21 CFR 878.4010) Predicate Device(s): LiquiBand® Ultima (Ki100284) Dermabond Nx (K100423) Dermabond (P960052) SurgiSeal (K082993)… | 2010 |
| * | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Summary page 1…te Device(s): LiquiBand® Ultima (Ki100284) Dermabond Nx (K100423) Dermabond (P960052) SurgiSeal (K082993) Derma+Flex OS (K101276) Device… | 1998 |
| * | K082993 | Surgiseal Topical Skin AdhesiveSummary page 1…) Dermabond Nx (K100423) Dermabond (P960052) SurgiSeal (K082993) Derma+Flex OS (K101276) Device Description: Banle Tissue Adhesive is a… | 2008 |
| * | K101276 | Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404Summary page 1…Dermabond (P960052) SurgiSeal (K082993) Derma+Flex OS (K101276) Device Description: Banle Tissue Adhesive is a sterile, topical tissue adhesive… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132243 | Barle Tissue Adhesive 2 | 2013 | 2 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K132243 (Advanced Medical Solutions (Plymouth), Ltd., 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K100284.
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. 2013, 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?
Banle Tissue Adhesive topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. Banle Tissue Adhesive 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/K123133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123133: Barle Tissue Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123133
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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