Fibre Formations, Inc.: FDA clearances and approvals
Fibre Formations, Inc. has 5 FDA 510(k) clearances (first 1978, latest 1979), across 3 product codes in 3 review panels. Median 510(k) review time: 28 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | 2 | 2 |
| FMP | Protector, Skin Pressure | 2 | 2 |
| BTX | Board, Arm (With Cover), Sterile | 1 | 1 |
Review panels
Most recent Fibre Formations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K791709 | HEEL/ELBOW PROTECTORS | FMP | 1979-09-24 | 28 |
| K790922 | DISPOSABLE ADULT DIAPER | EYQ | 1979-07-30 | 76 |
| K781930 | PANT LINER, DISP. INCONTINENT | EYQ | 1979-02-01 | 78 |
| K781233 | IV ARMBOARDS | BTX | 1978-08-14 | 26 |
| K781246 | FOAM COMFORT RINGS | FMP | 1978-08-10 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Fibre Formations, Inc..
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 Fibre Formations, Inc. have?
Fibre Formations, Inc. has 5 FDA 510(k) clearances (first 1978, latest 1979), across 3 product codes in 3 review panels.
How long does FDA take to clear Fibre Formations, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Fibre Formations, Inc.'s cleared 510(k)s is 28 days.
What devices does Fibre Formations, Inc. make?
Its most frequent FDA product codes are EYQ (Garment, Protective, For Incontinence, 2); FMP (Protector, Skin Pressure, 2); BTX (Board, Arm (With Cover), Sterile, 1).
Has Fibre Formations, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fibre Formations, Inc. Related entities may recall under other names.
Next steps
- See all 5 Fibre Formations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EYQ, Fibre Formations, Inc.'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.