510(k) · Cleared
ClearedAesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Feb 6, 2012 as substantially equivalent to P050013 (Tissue Seal, LLC, 2007) after a 210-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Feb 6, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P050013 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP050013 Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC · 2007
- This deviceK111959 Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK121976 Aesculap Histoacryl Flexible Topical Skin AdhesiveAesculap, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140343 Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical…Aesculap, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −1 | P050013 | Histoacryl and Histoacryl Blue Topical Skin Adhesive | Tissue Seal, LLC | 2007 | — |
| 0 (this device) | K111959 | Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive | Aesculap, Inc. | 2012 | — |
| +1 | K121976 | Aesculap Histoacryl Flexible Topical Skin Adhesive | Aesculap, Inc. | 2013 | — |
| +1 | K140343 | Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin… | Aesculap, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P050013 | Histoacryl and Histoacryl Blue Topical Skin AdhesiveSummary page 2…ryl WeC4p9 Blue Topical Skin Adhesive, Tissue 14subt ,allYequivalent to Histoacryl and am1w (P050013). The only difference isthe packaging. (pUPRO FFR PREMARKET NOTIFICATION N~t… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K121976 (Aesculap, Inc., 2013) 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. 2012, 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?
Histoacryl and Histoacryl Blue topical skin adhesives are intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations.
Histoacryl and Histoacryl Blue may be used in conjunction with, but not in place of, dermal sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111959: Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111959
Report an extraction error
Are you the manufacturer?
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