Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Percutaneous Technologies · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904479 | SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 | Percutaneous Technologies | 1990-11-02 | 31 | 0 |
| K903213 | ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002 | Percutaneous Technologies | 1990-07-27 | 4 | 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