Absorbent Cotton Co., Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Absorbent Cotton Co., Inc.” (first 1978, latest 1988), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 36 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 | 2 | 2 |
| GEC | Brush, Scrub, Operating-Room | 2 | 2 |
| NAD | Dressing, Wound, Occlusive | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GOY | Antisera, Agglutinating, B. Pertussis, All | 1 | 1 |
| LRO | General Surgery Tray | 1 | 1 |
Review panels
Most recent Absorbent Cotton Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883250 | STERI-CLENS WOUND CARE KIT | LRO | 1988-08-26 | 24 |
| K880613 | ACCO(R) FACE MASK | FXX | 1988-03-04 | 17 |
| K875129 | STERI-CLENS | GEC | 1988-02-18 | 65 |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | GEC | 1987-12-10 | 17 |
| K873523 | PLAIN DRY GAUZE | EFQ | 1987-10-09 | 38 |
| K854740 | PRIMADERM | NAD | 1986-03-14 | 109 |
| K850126 | OIL EMULSION NON-ADHERING DRESSING | FRO | 1985-04-25 | 101 |
| K844095 | WET DRESSING WATER-STERILE | NAD | 1984-11-27 | 35 |
| K844096 | WET DRESSING SALINE-STERILE | FRO | 1984-11-19 | 27 |
| K781727 | CHANGE IN STERILIZATION PROCEDURE | GOY | 1978-12-04 | 54 |
Recalls
openFDA lists no recalls under a recalling firm named Absorbent Cotton Co., 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 Absorbent Cotton Co., Inc.?
FDA lists 10 510(k) clearances under the applicant name “Absorbent Cotton Co., Inc.” (first 1978, latest 1988), across 7 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 Absorbent Cotton Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Absorbent Cotton Co., Inc. is 36 days.
Which FDA product codes appear under Absorbent Cotton Co., Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 2); GEC (Brush, Scrub, Operating-Room, 2); NAD (Dressing, Wound, Occlusive, 2).
Next steps
- See all 10 Absorbent Cotton Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Absorbent Cotton Co., 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.