Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Noble Fiber Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
305 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063190 | SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC | Noble Fiber Technologies, Inc. | 2007-08-21 | 305 | 0 |
| K050726 | SILVERSEAL SILVERAID WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-12-05 | 262 | 0 |
| K051256 | SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-07-21 | 66 | 0 |
| K050649 | SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-06-13 | 91 | 0 |
| K043526 | SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC | Noble Fiber Technologies, Inc. | 2005-03-10 | 79 | 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