510(k) · Cleared
Recalled · Class III · 2022Barle Tissue Adhesive 2
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 Dec 20, 2013 as substantially equivalent to K123133 (Advanced Medical Solutions (Plymouth), Ltd., 2013) and 1 other predicate after a 155-day review. Its family tree reaches back 5 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2013
- Review
- 155 days
- Class
- Class II
- Product code
- MPN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to P010002 (2002). 10 ancestors in all, the oldest P960052 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
- 4 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
- 3 generations backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
- 2 generations backK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
- 1 generation backK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012 · Recalled
- This deviceK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK151182 LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK183570 LiquiBand PlusAdvanced Medical Solutions Limited · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P010002 | Indermil (TM) Tissue Adhesive | Covidien Lp, Formerly Registered AS United States | 2002 | — |
| −4 | K083531 | Liquiband Ultima, Model LB0004 | Medlogic Global, Ltd. | 2009 | — |
| −3 | K100284 | Liquiband Ultima, Lut 003 | Medlogic Global Limited | 2010 | — |
| −2 | K110184 | Liquiband Flow Control | Medlogic Global Limited | 2011 | — |
| −1 | K122446 | Liquidband Flow Control | Advanced Medical Solutions (Plymouth), Ltd. | 2012 | 1 |
| 0 (this device) | K132243 | Barle Tissue Adhesive 2 | Advanced Medical Solutions (Plymouth), Ltd. | 2013 | — |
| +1 | K151182 | LiquiBand Exceed | Advanced Medical Solutions (Plymouth), Ltd. | 2015 | — |
| +2 | 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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123133 | Barle Tissue AdhesiveSummary page 1…Tissue Adhesive (21 CFR 875,4010) Name: Product Code: MPN Predicate Badle Tissue Adhesive (K123133) Device(s): LiquiBando (KI 22446) Device Bade Tissue Adhesive… | 2013 |
| * | K122446 | Liquidband Flow ControlSummary page 2…Tissue Adhesive,2 is substantially eqiuivalent to Bade Equivalence: Tissue Adhesive (K1 23133) and LiquiBando Flow Control Topical Skin Adhesive (K1 22446) with regard to Indication For Use, target population, intended application, mechanism of action and… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151182 | LiquiBand Exceed | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class III | Z-1788-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
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 1.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K151182 (Advanced Medical Solutions (Plymouth), Ltd., 2015) has gone furthest, with 1 descendant 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. 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 2 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. Bade Tissue Adhesive 2 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/K132243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132243: Barle Tissue Adhesive 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132243
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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