Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transcorp, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121178 | TRANSCORP ACIF SYSTEM | Transcorp, Inc. | 2013-07-05 | 443 | 0 |
| K113352 | TRANSCORP SPINAL ACCESS SYSTEM | Transcorp, Inc. | 2012-04-16 | 154 | 0 |
| K092794 | TRANSCORP ACIF SYSTEM | Transcorp, Inc. | 2010-09-13 | 367 | 0 |
| K092695 | TRANSCORP TRANS-PLATE ANTERIOR CERVICAL PLATE SYSTEM | Transcorp, Inc. | 2010-05-21 | 261 | 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