Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healthium Medtech Limited · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Healthium Medtech Limited | 2024-01-04 | 268 | 0 |
| K230891 | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implan | Healthium Medtech Limited | 2023-12-28 | 272 | 0 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited | 2023-11-08 | 51 | 0 |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close | Healthium Medtech Limited | 2023-08-04 | 81 | 0 |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Healthium Medtech Limited | 2023-03-22 | 85 | 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