510(k) Report

510(k) · Cleared

Recalled · Class III · 2022

Liquidband Flow Control

K122446510(k) TraditionalCleared Oct 26, 201277-day reviewClass II21 CFR 878.4010Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Medical Solutions (Plymouth), Ltd. · MPN Tissue Adhesive For The Topical Approximation Of Skin

Cleared on Oct 26, 2012 as substantially equivalent to K110184 (Medlogic Global Limited, 2011) after a 77-day review. Its family tree reaches back 4 generations to 2002. 5 later devices descend from it. It has been recalled once.

Decided
Oct 26, 2012
Review
77 days
Class
Class II
Product code
MPN
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to P010002 (2002). 5 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2014: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant clearedP010002 · Indermil (TM) Tissue Adhesive · Covidien Lp, Formerly Registered AS United States · 2002K083531 · Liquiband Ultima, Model LB0004 · Medlogic Global, Ltd. · 2009K100284 · Liquiband Ultima, Lut 003 · Medlogic Global Limited · 2010K110184 · Liquiband Flow Control · Medlogic Global Limited · 2011200020052010201520202025
  1. Root · 4 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
  2. 3 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
  3. 2 generations backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
  4. 1 generation backK110184 Liquiband Flow ControlMedlogic Global Limited · 2011
  5. This deviceK122446 Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd. · 2012
  6. Descendant · cites it directly · 2 of its ownK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · Recalled
  7. Descendant · 2 generations on · 1 of its ownK151182 LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd. · 2015
  8. Descendant · cites it directly · 1 of its ownK140517 Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014
  9. Descendant · 3 generations on · 0 of its ownK183570 LiquiBand PlusAdvanced Medical Solutions Limited · 2020
  10. Descendant · 2 generations on · 0 of its ownK141215 Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014

Most influential descendants

Showing 5 of 5 · See all
  • K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly2descendants
  • K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd. · 2015 · 2 generations on1descendant
  • K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014 · cites it directly1descendant
  • K183570LiquiBand PlusAdvanced Medical Solutions Limited · 2020 · 3 generations on0descendants
  • K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4P010002Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States2002—
−3K083531Liquiband Ultima, Model LB0004Medlogic Global, Ltd.2009—
−2K100284Liquiband Ultima, Lut 003Medlogic Global Limited2010—
−1K110184Liquiband Flow ControlMedlogic Global Limited2011—
0 (this device)K122446Liquidband Flow ControlAdvanced Medical Solutions (Plymouth), Ltd.2012—
+1K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd.20131
+2K151182LiquiBand ExceedAdvanced Medical Solutions (Plymouth), Ltd.2015—
+1K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC2014—
+3K183570LiquiBand PlusAdvanced Medical Solutions Limited2020—
+2K141215Surgiseal Twist Topical Skin AdhesiveAdhezion Biomedical, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201510
202010
FIG. 1 — Lineage of K122446, 2002–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K234114 CUTIVA (TM) Topical Skin Adhesive (RM-1700)…score 11.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K110184Liquiband Flow Control
Summary page 2
…have not been established. Substantial Equivalence: LiquiBand® Flow Control is identical to the predicate device (K1 10184) Testing Summary: Microbial barrier testing was conducted using LiquiBand Flow…
Medlogic Global Limited2011—

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd.20132
K140517Surgiseal Topical Skin Adhesive/Surgiseal Stylus Topical Skin AdhesiveAdhezion Biomedical, LLC20141

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2022Class IIIZ-1788-2022Environmental controlFacility 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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K132243 (Advanced Medical Solutions (Plymouth), Ltd., 2013) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MPN devices

MPN Tissue Adhesive For The Topical Approximation Of Skin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MPN

2in 2025

2007: 12008: 12009: 12010: 32011: 22012: 22013: 62014: 42015: 42016: 52020: 22021: 12024: 32025: 2
2007high 6 (2013) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MPN

266in 2024

2010: 77 days median2013: 193 days median2014: 96 days median2015: 141 days median2016: 173 days median2024: 266 days median
2007high 266 (2024) · low 77 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MPN

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MPN

244in 2025

2007: 562008: 322009: 222010: 212011: 932012: 1352013: 1772014: 1992015: 1792016: 1942017: 1822018: 2722019: 4272020: 2252021: 1412022: 1652023: 1302024: 2362025: 244
2007high 427 (2019) · low 21 (2010)2025

MAUDE reports naming product code MPN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—056
20081—032
20091—022
2010377021
20112—093
20122—0135
201361930177
20144960199
201541410179
201651730194
20170—0182
20180—0272
20190—0427
20202—0225
20211—1141
20220—0165
20230—0130
202432660236
20252—0244
20260—0—

What is it indicated for?

LiquiBand Flow Control 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. LiquiBand Flow Control 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.

Cite this page

510(k) Report. “K122446: Liquidband Flow Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122446

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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