Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Absorbent Cotton Co., Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
109 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883250 | STERI-CLENS WOUND CARE KIT | Absorbent Cotton Co., Inc. | 1988-08-26 | 24 | 0 |
| K880613 | ACCO(R) FACE MASK | Absorbent Cotton Co., Inc. | 1988-03-04 | 17 | 0 |
| K875129 | STERI-CLENS | Absorbent Cotton Co., Inc. | 1988-02-18 | 65 | 0 |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | Absorbent Cotton Co., Inc. | 1987-12-10 | 17 | 0 |
| K873523 | PLAIN DRY GAUZE | Absorbent Cotton Co., Inc. | 1987-10-09 | 38 | 0 |
| K854740 | PRIMADERM | Absorbent Cotton Co., Inc. | 1986-03-14 | 109 | 0 |
| K850126 | OIL EMULSION NON-ADHERING DRESSING | Absorbent Cotton Co., Inc. | 1985-04-25 | 101 | 0 |
| K844095 | WET DRESSING WATER-STERILE | Absorbent Cotton Co., Inc. | 1984-11-27 | 35 | 0 |
| K844096 | WET DRESSING SALINE-STERILE | Absorbent Cotton Co., Inc. | 1984-11-19 | 27 | 0 |
| K781727 | CHANGE IN STERILIZATION PROCEDURE | Absorbent Cotton Co., Inc. | 1978-12-04 | 54 | 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