FDA product code MDA: Elastomer, Silicone, For Scar Management
MDA is the FDA product code for elastomer, silicone, for scar management. It is a Class I device, regulated under 21 CFR 878.4025 and reviewed by the General and Plastic Surgery panel. FDA has cleared 81 510(k) submissions under MDA, from 52 different applicants. The average 510(k) review took 122 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Regulation | 21 CFR 878.4025 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MDA clearance
Top MDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio Med Sciences, Inc. | 7 | 2002-10-16 |
| Biodermis Corp. | 4 | 2001-01-29 |
| Implantech Associates, Inc. | 3 | 2002-02-07 |
| Pmt Corp. | 3 | 1997-10-01 |
| Silipos, Inc. | 3 | 1996-02-28 |
47 more applicants have MDA clearances. See the full list in Caduvo.
Most recent MDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112131 | Neodyne Biosciences, Inc. | NEODYNE DRESSING | 2011-09-29 | 65 |
| K111733 | Coreleader Biotech Co., Ltd. | CORELEADER SCAR-DIMMER | 2011-09-22 | 93 |
| K083718 | Beau RX Solutions, LLC | BEAU RX SCAR CARE GEL | 2009-01-26 | 42 |
| K053481 | Advanced Bio-Technologies, Inc. | KELO-COTE SPRAY | 2006-04-14 | 121 |
| K041704 | Newmedical Technology, Inc. | NEWGEL AND NEWGEL PLUS E | 2005-10-17 | 481 |
Recalls for MDA devices
openFDA lists no recalls for product code MDA.
Frequently asked questions
What is FDA product code MDA?
MDA is the FDA product code for elastomer, silicone, for scar management. It is a Class I device, regulated under 21 CFR 878.4025 and reviewed by the General and Plastic Surgery panel.
What device class is MDA?
Class I, regulation 21 CFR 878.4025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MDA?
Across 81 cleared submissions the average was 122 days from receipt to decision (median 90).
Which companies have the most MDA clearances?
Bio Med Sciences, Inc. (7); Biodermis Corp. (4); Implantech Associates, Inc. (3); Pmt Corp. (3); Silipos, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code MDA
- Run a recall and safety report across every MDA manufacturer
- Watch product code MDA 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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