James River Corp.: FDA clearances and approvals
James River Corp. has 15 FDA 510(k) clearances (first 1983, latest 1989), across 11 product codes in 2 review panels. Median 510(k) review time: 38 days.
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 |
|---|---|---|---|
| FXP | Cover, Shoe, Operating-Room | 3 | 3 |
| FRG | Wrap, Sterilization | 2 | 2 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| FXY | Hood, Surgical | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| FYF | Cap, Surgical | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent James River Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K894505 | COTOLIN DRAIN SPONGE AND DRESSING SPONGE | EFQ | 1989-09-15 | 58 |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | KGX | 1989-08-09 | 56 |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | KGO | 1989-07-14 | 38 |
| K893939 | ISOLATION MASKS | FXX | 1989-07-14 | 44 |
| K892580 | CARETOUCH EXAMINATION GLOVES | LYY | 1989-07-14 | 95 |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | KGO | 1989-04-20 | 80 |
| K883802 | CARETEX CENTRAL SUPPLY WRAP | FRG | 1988-10-21 | 44 |
| K884112 | CARETEX OR TOWEL | KKX | 1988-10-13 | 14 |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | FXP | 1988-09-15 | 20 |
| K880481 | CARETEX SURGEON'S CAPS | FYF | 1988-02-24 | 19 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named James River Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does James River Corp. have?
James River Corp. has 15 FDA 510(k) clearances (first 1983, latest 1989), across 11 product codes in 2 review panels.
How long does FDA take to clear James River Corp.'s 510(k)s?
The median time from FDA receipt to decision across James River Corp.'s cleared 510(k)s is 38 days.
What devices does James River Corp. make?
Its most frequent FDA product codes are FXP (Cover, Shoe, Operating-Room, 3); FRG (Wrap, Sterilization, 2); KGO (Surgeon'S Gloves, 2).
Has James River Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching James River Corp. Related entities may recall under other names.
Next steps
- See all 15 James River Corp. clearances with predicates and recalls
- Run predicate analysis for product code FXP, James River Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.