Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
First Industries, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
21 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810652 | TUBING CONNECTORS | First Industries, Inc. | 1981-03-31 | 21 | 0 |
| K810651 | ORAL AIRWAYS | First Industries, Inc. | 1981-03-31 | 21 | 0 |
| K810653 | VINYL ICE BAG | First Industries, Inc. | 1981-03-27 | 17 | 0 |
| K810654 | STOPPERLESS HOT/COLD RUBBER WATER BOTTLE | First Industries, Inc. | 1981-03-27 | 17 | 0 |
| K810650 | CRUTCH TIPS & GRIPS | First Industries, Inc. | 1981-03-26 | 16 | 0 |
| K810649 | INVALID CUSHION | First Industries, Inc. | 1981-03-26 | 16 | 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