510(k) · Cleared
ClearedBondease Topical Skin Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optmed, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Dec 22, 2015 as substantially equivalent to P960052 (Closure Medical Corp., 1998) and 1 other predicate after a 596-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Dec 22, 2015
- Review
- 596 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P960052 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate) | Closure Medical Corp. | 1998 | 2 |
| 0 (this device) | K141157 | Bondease Topical Skin Adhesive | Optmed, Inc. | 2015 | — |
| +1 | K243990 | BondEase 2 Topical Skin Adhesive | Optmed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | P960052 | Dermabond (a Formulation of 2-Octyl Cyanoacrylate)Summary page 4…Plastic Surgery Product Code MPN Regulation Class II, 21 C.F.R. § 878.4010 Predicate Devices: DERMABOND® Topical Skin Adhesive (P960052) INDERMIL® Tissue Adhesive (P010002) Device Description BondEase® Topical Skin Adhesive is a… | 1998 |
| * | P010002 | Indermil (TM) Tissue AdhesiveSummary page 4…Class II, 21 C.F.R. § 878.4010 Predicate Devices: DERMABOND® Topical Skin Adhesive (P960052) INDERMIL® Tissue Adhesive (P010002) Device Description BondEase® Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a meth… | 2002 |
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 |
|---|---|---|---|
| K243990 | BondEase 2 Topical Skin Adhesive | 2025 | 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?
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. 2015, 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?
BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141157: Bondease 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/K141157
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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