Acrymed, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Acrymed, Inc.” (first 1994, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 66 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 9 | 9 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 3 | 3 |
| KMF | Bandage, Liquid | 2 | 2 |
Review panels
Most recent Acrymed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091354 | ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING | FRO | 2009-10-21 | 166 |
| K083103 | ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B | FRO | 2009-02-26 | 129 |
| K082459 | ACRYDERM ABSORBENT OXYGEN DRESSING | FRO | 2008-09-19 | 24 |
| K070333 | ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL | FRO | 2007-07-10 | 155 |
| K061232 | ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 | FRO | 2006-10-06 | 157 |
| K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | MGQ | 2001-11-08 | 135 |
| K012116 | ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING | FRO | 2001-09-12 | 68 |
| K002909 | ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 | FRO | 2000-10-13 | 25 |
| K002599 | MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | FRO | 2000-09-21 | 31 |
| K991818 | ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | FRO | 2000-04-17 | 326 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acrymed, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Acrymed, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Acrymed, Inc.” (first 1994, latest 2009), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acrymed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acrymed, Inc. is 66 days.
Which FDA product codes appear under Acrymed, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 9); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 3); KMF (Bandage, Liquid, 2).
Next steps
- See all 14 Acrymed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Acrymed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.