510(k) Report

510(k) · Cleared

Cleared

Liquiband Dual, Model LBD 001

K102076510(k) TraditionalCleared Feb 18, 2011207-day reviewClass II21 CFR 878.4010

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

Medlogic Global Limited · MPN Tissue Adhesive For The Topical Approximation Of Skin

Cleared on Feb 18, 2011 as substantially equivalent to K100284 (Medlogic Global Limited, 2010) after a 207-day review. Its family tree reaches back 3 generations to 2002.

Decided
Feb 18, 2011
Review
207 days
Class
Class II
Product code
MPN
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to P010002 (2002). No later device cites it as a predicate yet.

  1. Root · 3 generations backP010002 Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States · 2002
  2. 2 generations backK083531 Liquiband Ultima, Model LB0004Medlogic Global, Ltd. · 2009
  3. 1 generation backK100284 Liquiband Ultima, Lut 003Medlogic Global Limited · 2010
  4. This deviceK102076 Liquiband Dual, Model LBD 001Medlogic Global Limited · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3P010002Indermil (TM) Tissue AdhesiveCovidien Lp, Formerly Registered AS United States2002—
−2K083531Liquiband Ultima, Model LB0004Medlogic Global, Ltd.2009—
−1K100284Liquiband Ultima, Lut 003Medlogic Global Limited2010—
0 (this device)K102076Liquiband Dual, Model LBD 001Medlogic Global Limited2011—
FIG. 1 — Lineage of K102076, 2002–2011Source: 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
*K100284Liquiband Ultima, Lut 003
Summary page 1
…Topical Skin Adhesive Classification Name: Tissue Adhesive (21 CFR 878.4010) Predicate Device(s): Liqujanda Ultinia (K100284) Device Description: LiquiBand® Dual is a sterile, topical tissue adhesive containing…
Medlogic Global Limited2010—

Also cleared against K100284: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K100284.

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. 2011, 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 Dual 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 Dual 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. “K102076: Liquiband Dual, Model LBD 001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102076

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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