510(k) · Cleared
ClearedAesculap Histoacryl Flexible 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 May 17, 2013 as substantially equivalent to K111959 (Aesculap, Inc., 2012) and 1 other predicate after a 316-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- May 17, 2013
- Review
- 316 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P050013 (2007). 3 ancestors in all, the oldest P960052 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backP050013 Histoacryl and Histoacryl Blue Topical Skin AdhesiveTissue Seal, LLC · 2007
- 1 generation backK111959 Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveAesculap, Inc. · 2012
- This deviceK121976 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 1 of 1 · See all- K140343Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with…Aesculap, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P050013 | Histoacryl and Histoacryl Blue Topical Skin Adhesive | Tissue Seal, LLC | 2007 | — |
| −1 | K111959 | Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive | Aesculap, Inc. | 2012 | — |
| 0 (this device) | K121976 | Aesculap Histoacryl Flexible Topical Skin Adhesive | Aesculap, Inc. | 2013 | — |
| +1 | K140343 | Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin… | Aesculap, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K111959 | Aesculap Histoacryl and Histoacryl Blue Topical Skin AdhesiveSummary page 2…;, Inc: believes thattthe, Histoacryl Ftexible Topical Skin Adhesive is substantially equivalent to the Aesculap Hifstoacryl and I-Iistoacryl Blue Topical Skin Adhesive (K1 11959).and Dermabond (P9,600652). PURPOSE FOR PREMARKET NOTIFICATION The purposefor this submission is to gain marketing clearance for… | 2012 |
| * | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Summary page 2…pical Skin Adhesive are equivalent in performance to the predicate devices Histoacryl and Histoacryl blue Topical Skin Adhesive, Aes-s6lap mInd (KilI 959)-and Dermabond (P960052). The subject device is shown to'be substantially equivalent and has the same performance characteristic to ,the predicate device… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140343 | Aesculap Histoacryl, Histoacryl Blue and Histoacryl Flexible Topical Skin, Adhesive with… | 2014 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140343 (Aesculap, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K111959.
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. 2013, 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 Flexible topical skin adhesive Is 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 Flexible may be used in conjunction with, but not in place of, deep dermal sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121976 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121976: Aesculap Histoacryl Flexible Topical Skin Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121976
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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