510(k) Report

510(k) · Cleared

Cleared

Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404

K101276510(k) TraditionalCleared Jul 28, 201083-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

Chemence Medical Products, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin

Cleared on Jul 28, 2010 after an 83-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Jul 28, 2010
Review
83 days
Class
Class II
Product code
MPN
Recalls
None
Predicates
0

13 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2013: 4 descendants cleared2014: 3 descendants cleared2020: 2 descendants cleared2015: 1 descendant cleared2021: 1 descendant cleared2010201520202025
  1. This deviceK101276 Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404Chemence Medical Products, Inc. · 2010
  2. Descendant · cites it directly · 3 of its ownK130474 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013
  3. Descendant · cites it directly · 3 of its ownK123133 Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013
  4. Descendant · cites it directly · 2 of its ownK152476 Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016
  5. Descendant · 2 generations on · 2 of its ownK132243 Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · Recalled
  6. Descendant · cites it directly · 2 of its ownK123936 Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 42014: 32015: 12016: 22020: 22021: 1
2013high 4 (2013) · low 0 (2017)2026

Most influential descendants

Showing 5 of 13 · See all
  • K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly3descendants
  • K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd. · 2013 · cites it directly3descendants
  • K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016 · cites it directly2descendants
  • K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd. · 2013 · 2 generations on2descendants
  • K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC · 2013 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101276Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404Chemence Medical Products, Inc.2010—
+1K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—
+1K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.2013—
+1K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.2016—
+2K132243Barle Tissue Adhesive 2Advanced Medical Solutions (Plymouth), Ltd.20131
+1K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201340
201430
201510
201620
202020
202110
FIG. 1 — Lineage of K101276, 2010–2021Source: 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
*—High Viscosity Dermabond Topical Skin Adhesive
Named without a submission number
—

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K130474Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20133
K123133Barle Tissue AdhesiveAdvanced Medical Solutions (Plymouth), Ltd.20133
K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc.20162
K123936Surgiseal Topical Skin AdhesiveAdhezion Biomedical, LLC20132
K162352derma+flex QS High Viscosity Tissue AdhesiveChemence Medical, Inc.20160

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?

  • Of its descendants, K130474 (Adhezion Biomedical, LLC, 2013) has gone furthest, with 3 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. 2010, 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?

derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application 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. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Indications for use as stated in the FDA summary.

More from Chemence Medical Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. · 2016

Recent decisions in MPN

The MPN category page

  • K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc. · 2025
  • K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical · 2025
  • K234114CUTIVA (TM) Topical Skin Adhesive (RM-1700); CUTIVA (TM) PLUS Skin Closure System (RM-1739)Okapi Medical, LLC Dba Resivant Medical · 2024
  • K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical, Ltd. · 2024
  • K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited. · 2024

https://510kreport.com/device/K101276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101276: Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101276

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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