The Buckeye Cellulose Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “The Buckeye Cellulose Corp.” (first 1980, latest 1983), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| FYA | Gown, Surgical | 7 | 7 |
| KKX | Drape, Surgical, Antimicrobial | 5 | 5 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| GEC | Brush, Scrub, Operating-Room | 1 | 1 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
Review panels
Most recent The Buckeye Cellulose Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K822925 | BOUNDARY SINGLE-USE GOWNS | FYA | 1983-01-12 | 103 |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | GEC | 1982-11-22 | 27 |
| K821564 | BOUNDARY PROCESS CHANGE | FYA | 1982-07-02 | 38 |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | KKX | 1982-04-29 | 38 |
| K820116 | BOUNDARY | FYA | 1982-02-23 | 36 |
| K813450 | BOUNDARY SINGLE-USE DRAPES | KKX | 1982-01-22 | 43 |
| K813390 | BONDARY SINGLE-USE OR GOWN | FYA | 1982-01-05 | 33 |
| K813277 | BOUNDARY DRAPE TAPE | KKX | 1981-12-18 | 25 |
| K813263 | PATIENT UNDERPAD | KME | 1981-11-27 | 7 |
| K812962 | BOUNDARY SURGICAL DRAPE | KKX | 1981-11-20 | 29 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Buckeye Cellulose 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Buckeye Cellulose Corp.?
FDA lists 18 510(k) clearances under the applicant name “The Buckeye Cellulose Corp.” (first 1980, latest 1983), across 8 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 The Buckeye Cellulose Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Buckeye Cellulose Corp. is 34 days.
Which FDA product codes appear under The Buckeye Cellulose Corp.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 7); KKX (Drape, Surgical, Antimicrobial, 5); FRG (Wrap, Sterilization, 1).
Next steps
- See all 18 The Buckeye Cellulose Corp. clearances with predicates and recalls
- Run predicate analysis for product code FYA, The Buckeye Cellulose 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, 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.