Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hydrofera, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
362 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190268 | Hydrofera Blue READY - Border | Hydrofera, LLC | 2019-11-06 | 271 | 0 |
| K130670 | HYDROFERA BLUE PU BACTERIOSTATIC DRESSING | Hydrofera, LLC | 2014-01-02 | 296 | 0 |
| K023138 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Hydrofera, LLC | 2003-01-17 | 119 | 0 |
| K013462 | HYDROFERA BACTERIOSTATIC WOUND DRESSING | Hydrofera, LLC | 2002-01-11 | 85 | 0 |
| K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | Hydrofera, LLC | 1999-09-14 | 362 | 0 |
| K974313 | HYDROFERA SURGICAL SPEAR | Hydrofera, LLC | 1998-03-02 | 105 | 0 |
| K974316 | HYDROFERA FEMORAL WICK | Hydrofera, LLC | 1998-02-13 | 88 | 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