Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3-D Matrix, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
254 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K222481 | PuraStat | 3-D Matrix, Inc. | 2023-02-28 | 195 | 0 |
| K213552 | PuraStat-RM | 3-D Matrix, Inc. | 2022-04-01 | 144 | 0 |
| K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021-10-08 | 254 | 0 |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021-06-25 | 162 | 0 |
| K193085 | PuraDERM Gel | 3-D Matrix, Inc. | 2020-05-11 | 188 | 0 |
| K183015 | PuraSinus | 3-D Matrix, Inc. | 2019-04-12 | 163 | 0 |
| K143058 | PuraDerm Gel | 3-D Matrix, Inc. | 2015-02-13 | 112 | 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