510(k) Report

PMA · Approved

Approved

Histoacryl and Histoacryl Blue Topical Skin Adhesive

P050013PMAApproved Feb 16, 2007693-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

Tissue Seal, LLC · MPN Tissue Adhesive For The Topical Approximation Of Skin

Approved on Feb 16, 2007 through premarket approval, which rests on the device’s own clinical evidence after a 693-day review. 3 later devices descend from it.

Decided
Feb 16, 2007
Review
693 days
Class
Class II
Product code
MPN
Recalls
None

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared20052010201520202025
  1. This deviceP050013 Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC · 2007
  2. Descendant · cites it directly · 2 of its ownK111959 Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc. · 2012
  3. Descendant · 2 generations on · 1 of its ownK121976 Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc. · 2013
  4. Descendant · 2 generations on · 0 of its ownK140343 Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical…Aesculap, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K111959Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc. · 2012 · cites it directly2descendants
  • K121976Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc. · 2013 · 2 generations on1descendant
  • K140343Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with…Aesculap, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P050013Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC2007—
+1K111959Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc.2012—
+2K121976Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc.2013—
+2K140343Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin…Aesculap, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201410
FIG. 1 — Lineage of P050013, 2007–2014Source: 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 PMA database (decision fields and supplements), 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
Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111959Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc.20122

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, K111959 (Aesculap, Inc., 2012) 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. 2007, 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—

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/P050013 · printed Nov 5, 2026

Cite this page

510(k) Report. “P050013: Histoacryl and Histoacryl Blue Topical Skin Adhesive.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P050013

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026