Healthium Medtech Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Healthium Medtech Limited” (first 2023, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 85 days, against 74 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 4 | 83 |
| 2024 | 1 | 268 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Healthium Medtech Limited took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 74 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Healthium Medtech Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | MBI | 2024-01-04 | 268 |
| K230891 | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | MBI | 2023-12-28 | 272 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | MBI | 2023-11-08 | 51 |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | MBI | 2023-08-04 | 81 |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | MBI | 2023-03-22 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Healthium Medtech Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthium Medtech Limited?
FDA lists 5 510(k) clearances under the applicant name “Healthium Medtech Limited” (first 2023, latest 2024), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Healthium Medtech Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthium Medtech Limited is 85 days. Since 2017: 85 days, versus 74 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Healthium Medtech Limited?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 5).
Next steps
- See all 5 Healthium Medtech Limited clearances with predicates and recalls
- Run predicate analysis for product code MBI, Healthium Medtech Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.