Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pan Medical , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kypho | Pan Medical , Ltd. | 2016-11-01 | 61 | 0 |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) | Pan Medical , Ltd. | 2015-03-06 | 25 | 0 |
| K132620 | INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV | Pan Medical , Ltd. | 2014-04-16 | 238 | 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