Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Buckeye Cellulose Corp. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
91 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K822925 | BOUNDARY SINGLE-USE GOWNS | The Buckeye Cellulose Corp. | 1983-01-12 | 103 | 0 |
| K823173 | ARRIRM SCRUB BRUSH/SPONGE | The Buckeye Cellulose Corp. | 1982-11-22 | 27 | 0 |
| K821564 | BOUNDARY PROCESS CHANGE | The Buckeye Cellulose Corp. | 1982-07-02 | 38 | 0 |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | The Buckeye Cellulose Corp. | 1982-04-29 | 38 | 0 |
| K820116 | BOUNDARY | The Buckeye Cellulose Corp. | 1982-02-23 | 36 | 0 |
| K813450 | BOUNDARY SINGLE-USE DRAPES | The Buckeye Cellulose Corp. | 1982-01-22 | 43 | 0 |
| K813390 | BONDARY SINGLE-USE OR GOWN | The Buckeye Cellulose Corp. | 1982-01-05 | 33 | 0 |
| K813277 | BOUNDARY DRAPE TAPE | The Buckeye Cellulose Corp. | 1981-12-18 | 25 | 0 |
| K813263 | PATIENT UNDERPAD | The Buckeye Cellulose Corp. | 1981-11-27 | 7 | 0 |
| K812962 | BOUNDARY SURGICAL DRAPE | The Buckeye Cellulose Corp. | 1981-11-20 | 29 | 0 |
| K812738 | BOUNDARY PROCESS CHANGE | The Buckeye Cellulose Corp. | 1981-11-16 | 48 | 0 |
| K811819 | BOUNDARY STERILIZATION WRAP | The Buckeye Cellulose Corp. | 1981-08-04 | 36 | 0 |
| K811958 | BOUNDARY REINFORCED OR GOWN | The Buckeye Cellulose Corp. | 1981-07-27 | 18 | 0 |
| K810888 | BOUNDARY TUBING HOLDERS | The Buckeye Cellulose Corp. | 1981-04-23 | 21 | 0 |
| K803158 | IRRADIATED BOUNDARY DEVICES | The Buckeye Cellulose Corp. | 1981-01-15 | 55 | 0 |
| K801768 | CONTAIN X-RAY DETECTABLE LAP SPONGE | The Buckeye Cellulose Corp. | 1980-08-20 | 23 | 0 |
| K801024 | ODOR MASKING AGENT IN BOUNDARY OBSTETRI. | The Buckeye Cellulose Corp. | 1980-07-28 | 91 | 0 |
| K801025 | ODOR MASKING AGENT FOR CONTENTS OF ALL | The Buckeye Cellulose Corp. | 1980-05-30 | 32 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda