FDA product code MPN: Tissue Adhesive For The Topical Approximation Of Skin
MPN is the FDA product code for tissue adhesive for the topical approximation of skin. It is a Class II device, regulated under 21 CFR 878.4010 and reviewed by the General and Plastic Surgery panel. FDA has cleared 36 510(k) submissions under MPN, 5 in the last five years, from 16 different applicants. The average 510(k) review took 194 days (median 168); 240 days on average over the last three years. 3 PMA applications cite this product code. FDA has posted 2 recalls for MPN devices, 1 initiated in the last five years.
Definition
Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).
Classification
| Field | Value |
|---|---|
| Device name | Tissue Adhesive For The Topical Approximation Of Skin |
| Device class | Class II |
| Regulation | 21 CFR 878.4010 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for MPN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 381 |
| 2021 | 1 | 52 |
| 2024 | 3 | 283 |
| 2025 | 2 | 198 |
Compare with all 510(k) review times · Search every MPN clearance
Top MPN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adhezion Biomedical, LLC | 8 | 2016-11-08 |
| Advanced Medical Solutions (Plymouth), Ltd. | 4 | 2015-10-26 |
| Chemence Medical, Inc. | 3 | 2021-09-09 |
| Aesculap, Inc. | 3 | 2014-05-13 |
| Medlogic Global Limited | 3 | 2011-12-16 |
11 more applicants have MPN clearances. See the full list in Caduvo.
Most recent MPN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243990 | Optmed, Inc. | BondEase 2 Topical Skin Adhesive | 2025-09-19 | 267 |
| K250950 | Okapi Medical, LLC Dba Resivant Medical | CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739) | 2025-08-04 | 129 |
| K234114 | Okapi Medical, LLC Dba Resivant Medical | CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) | 2024-08-20 | 237 |
| K233458 | Connexicon Medical , Ltd. | CM005 Standard (CM005); CM004 Mini (CM004) | 2024-07-15 | 266 |
| K230981 | M/s. Meril Endo Surgery Private Limited. | Meriglu Topical Skin Adhesive | 2024-03-16 | 346 |
Recalls for MPN devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MPN?
MPN is the FDA product code for tissue adhesive for the topical approximation of skin. It is a Class II device, regulated under 21 CFR 878.4010 and reviewed by the General and Plastic Surgery panel.
What device class is MPN?
Class II, regulation 21 CFR 878.4010. Typical premarket route: 510(k).
How long does a 510(k) take for product code MPN?
Across 36 cleared submissions the average was 194 days from receipt to decision (median 168).
Which companies have the most MPN clearances?
Adhezion Biomedical, LLC (8); Advanced Medical Solutions (Plymouth), Ltd. (4); Chemence Medical, Inc. (3); Aesculap, Inc. (3); Medlogic Global Limited (3).
Have MPN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MPN
- Run a recall and safety report across every MPN manufacturer
- Watch product code MPN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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