Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PHN — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
144 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K253923 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 | 30 | 0 |
| K242634 | PuraStat | 3-D Matrix Europe SAS | 2025-01-15 | 134 | 0 |
| K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022-04-01 | 144 | 0 |
| K140558 | PROCTIGARD | Access Pharmaceuticals, Inc. | 2014-07-16 | 133 | 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