Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plastafil, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
154 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841620 | FRONT RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 | 154 | 0 |
| K841621 | BACK RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 | 154 | 0 |
| K841617 | STROVER HOOK | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841624 | PROBE | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841618 | THREADING TUBE | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841627 | MALLET | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841625 | HOOK | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841629 | DRILL BIT | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841626 | PUNCH | Plastafil, Inc. | 1984-08-27 | 130 | 0 |
| K841628 | WIRE | Plastafil, Inc. | 1984-07-23 | 95 | 0 |
| K841622 | SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | 83 | 0 |
| K841623 | SLOTTED SOFT-TISSUE INSTRUMENT | Plastafil, Inc. | 1984-07-11 | 83 | 0 |
| K841619 | DRILL GUIDE | Plastafil, Inc. | 1984-07-11 | 83 | 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