Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exciton Technologies, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
224 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182680 | KerraContact Ag Perf Advanced Perforated Silver Wound Dressi | Exciton Technologies, Inc. | 2018-12-06 | 71 | 0 |
| K162508 | KerraCel Ag Gelling Fiber Silver Dressing | Exciton Technologies, Inc. | 2017-02-13 | 158 | 1 |
| K133775 | EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING | Exciton Technologies, Inc. | 2014-03-26 | 104 | 0 |
| K113564 | EXSALT T7 WOUND DRESSING | Exciton Technologies, Inc. | 2011-12-15 | 13 | 0 |
| K103067 | EXSALT SD7 WOUND DRESSING | Exciton Technologies, Inc. | 2011-05-20 | 214 | 0 |
| K100580 | EXSALT WOUND DRESSING | Exciton Technologies, Inc. | 2010-10-12 | 224 | 0 |
| K083870 | EXSALT SD7 WOUND DRESSING | Exciton Technologies, Inc. | 2009-07-30 | 213 | 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