Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plastic Injectors, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
58 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884781 | OPTI-POINT | Plastic Injectors, Inc. | 1989-01-12 | 58 | 0 |
| K863423 | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 | Plastic Injectors, Inc. | 1986-09-16 | 12 | 0 |
| K863374 | CODE-A-WELL SERIES 1-600, 1-625 | Plastic Injectors, Inc. | 1986-09-11 | 8 | 0 |
| K844058 | CODE-A-WALL SERIES 1-250 INOCULUM TRAY | Plastic Injectors, Inc. | 1984-11-13 | 26 | 0 |
| K842848 | CODE-A-WELL 350 MICROTITRATION STRIPS | Plastic Injectors, Inc. | 1984-09-07 | 49 | 0 |
| K841632 | CODE-A-WELL SERIES 200 PLATE | Plastic Injectors, Inc. | 1984-05-25 | 35 | 0 |
| K841937 | CODE-A-WELL SERIES 300 PLATE | Plastic Injectors, Inc. | 1984-05-22 | 11 | 0 |
| K841390 | CODE-A-WELL | Plastic Injectors, Inc. | 1984-05-02 | 29 | 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