Nsp Tech Pte, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nsp Tech Pte, Ltd.” (first 2019, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 169 days. Since 2017 the median was 169 days, against 116 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 |
|---|---|---|
| 2019 | 2 | 393 |
| 2020 | 1 | 169 |
| 2021 | 0 | — |
| 2022 | 2 | 103 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nsp Tech Pte, Ltd. took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 | 2 |
Review panels
Most recent Nsp Tech Pte, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221783 | SafetiCET Safety Lancet | FMK | 2022-10-24 | 125 |
| K221604 | SafetiHeel, MediHeel, Novaplus | FMK | 2022-08-22 | 81 |
| K193074 | Bevel Up Holder | JKA | 2020-04-21 | 169 |
| K181754 | Blood Collection Accessory (BUCA) | JKA | 2019-07-30 | 393 |
| K181743 | Blood Transfer Accessory (BTA) | JKA | 2019-07-30 | 393 |
Recalls
openFDA lists no recalls under a recalling firm named Nsp Tech 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 Nsp Tech Pte, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Nsp Tech Pte, Ltd.” (first 2019, latest 2022), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nsp Tech Pte, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nsp Tech Pte, Ltd. is 169 days. Since 2017: 169 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nsp Tech Pte, Ltd.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 3); FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 2).
Next steps
- See all 5 Nsp Tech Pte, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Nsp Tech 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.