Noble Fiber Technologies, Inc.: FDA clearances and approvals
Noble Fiber Technologies, Inc. has 8 FDA 510(k) clearances (first 2004, latest 2007), across 5 product codes in 3 review panels. Median 510(k) review time: 230 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 4 | 4 |
| ISH | Component, External, Limb, Ankle/Foot | 1 | 1 |
| LGF | Component, Cast | 1 | 1 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 1 | 1 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 1 | 1 |
Review panels
Most recent Noble Fiber Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063190 | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC | QSY | 2007-08-21 | 305 |
| K050726 | SILVERSEAL SILVERAID WITH X-STATIC | FRO | 2005-12-05 | 262 |
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | ISH | 2005-07-21 | 66 |
| K050649 | SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC | FRO | 2005-06-13 | 91 |
| K043526 | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | LGF | 2005-03-10 | 79 |
| K033900 | X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING | FRO | 2005-01-14 | 394 |
| K033587 | SILVERSEAL | FRO | 2004-08-05 | 266 |
| K040019 | SILVERSEAL | MGQ | 2004-07-23 | 199 |
Recalls
openFDA lists no recalls under a recalling firm named Noble Fiber Technologies, 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 Noble Fiber Technologies, Inc. have?
Noble Fiber Technologies, Inc. has 8 FDA 510(k) clearances (first 2004, latest 2007), across 5 product codes in 3 review panels.
How long does FDA take to clear Noble Fiber Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Noble Fiber Technologies, Inc.'s cleared 510(k)s is 230 days.
What devices does Noble Fiber Technologies, Inc. make?
Its most frequent FDA product codes are FRO (Dressing, Wound, Drug, 4); ISH (Component, External, Limb, Ankle/Foot, 1); LGF (Component, Cast, 1).
Has Noble Fiber Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Noble Fiber Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 8 Noble Fiber Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Noble Fiber Technologies, 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.