Medipurpose Pte. , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medipurpose Pte. , Ltd.” (first 2010, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 152 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 24 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 59 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medipurpose Pte. , Ltd. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 | 4 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
Review panels
Most recent Medipurpose Pte. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222224 | SurgiLance® Safety Lancet | FMK | 2022-09-22 | 59 |
| K130132 | BABYLANCE HEEL INCISION DEVICE | FMK | 2013-02-11 | 24 |
| K110062 | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG | FRO | 2011-09-01 | 234 |
| K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | FMK | 2010-10-21 | 181 |
| K101417 | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 | FMK | 2010-10-19 | 152 |
Recalls
openFDA lists no recalls under a recalling firm named Medipurpose Pte. , Ltd..
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 Medipurpose Pte. , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Medipurpose Pte. , Ltd.” (first 2010, latest 2022), across 2 product codes 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 Medipurpose Pte. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medipurpose Pte. , Ltd. is 152 days.
Which FDA product codes appear under Medipurpose Pte. , Ltd.?
The most frequent FDA product codes under this applicant name are FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 4); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 5 Medipurpose Pte. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMK, Medipurpose Pte. , Ltd.'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.