510(k) · Cleared
Clearedderma+flex QS High Viscosity Tissue Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemence Medical, Inc. · MPN Tissue Adhesive For The Topical Approximation Of Skin
Cleared on Dec 22, 2016 as substantially equivalent to K101276 (Chemence Medical Products, Inc., 2010) after a 121-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Dec 22, 2016
- Review
- 121 days
- Class
- Class II
- Product code
- MPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101276 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK101276 Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404Chemence Medical Products, Inc. · 2010
- This deviceK162352 derma+flex QS High Viscosity Tissue AdhesiveChemence Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101276 | Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404 | Chemence Medical Products, Inc. | 2010 | — |
| 0 (this device) | K162352 | derma+flex QS High Viscosity Tissue Adhesive | Chemence Medical, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K101276 | Derma+Flex QS High Viscosity Tissue Adhesive Model: QS70404Summary page 4…) Regulatory Class: Class II Product Code: MPN 3. Predicate Devices Proprietary Name: derma+flex® QS™ 510(k) Clearance: K101276 4. Device Description derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a mo… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 4 other devices also cite its predicate K101276.
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. 2016, 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?
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 incisions 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.
https://510kreport.com/device/K162352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162352: derma+flex QS High Viscosity Tissue Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162352
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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