Acme United Corp.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Acme United Corp.” (first 1976, latest 1996), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 47 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | 5 | 5 |
| NAD | Dressing, Wound, Occlusive | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| GAD | Retractor | 2 | 2 |
| GEN | Forceps, General & Plastic Surgery | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| FPY | Sheet, Burn | 1 | 1 |
| FZQ | Clip, Removable (Skin) | 1 | 1 |
Plus 7 more product codes.
Review panels
Most recent Acme United Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | KMF | 1996-06-19 | 75 |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | KMF | 1996-05-31 | 45 |
| K952565 | LYOFOAM EXTRA | KMF | 1995-11-14 | 165 |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | KMF | 1990-09-10 | 349 |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | FPY | 1987-06-09 | 35 |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | FRO | 1986-11-21 | 32 |
| K860085 | LYOFOAM WOUND DRESSINGS | NAD | 1986-06-27 | 169 |
| K860818 | ONE TIME ENTERAL FEEDING BAG | KNT | 1986-05-15 | 72 |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | FOZ | 1986-04-22 | 35 |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | NAD | 1984-08-24 | 84 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acme United Corp..
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.
SEC filings
ACME UNITED CORP (ACU): EDGAR filings, CIK 2098. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Acme Medical Scale Co. (10 510(k)s)
- Acme-Monaco Corp. (5 510(k)s)
- Acme Spine, LLC (2 510(k)s)
- Acme Automatic Disposable (1 510(k)s)
- Acme Filter Mask, Inc. (1 510(k)s)
- Acme Medical, Inc. (1 510(k)s)
- Acme Portable Machines, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acme United Corp.?
FDA lists 27 510(k) clearances under the applicant name “Acme United Corp.” (first 1976, latest 1996), across 17 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acme United Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acme United Corp. is 47 days.
Which FDA product codes appear under Acme United Corp.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 5); NAD (Dressing, Wound, Occlusive, 3); FRO (Dressing, Wound, Drug, 2).
Next steps
- See all 27 Acme United Corp. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Acme United Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.