Poonglim Pharmatech, Inc.: FDA clearances and approvals
Poonglim Pharmatech, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 150 days. Since 2017 its median was 150 days, against 164 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 309 |
| 2019 | 0 | — |
| 2020 | 1 | 270 |
| 2021 | 2 | 0 |
| 2022 | 0 | — |
| 2023 | 1 | 445 |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Poonglim Pharmatech, Inc.'s cleared 510(k)s took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNQ | Low Dead Space Piston Syringe | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Poonglim Pharmatech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | QNQ | 2024-05-29 | 30 |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe | QNQ | 2023-09-15 | 445 |
| K210444 | EZ-Injec LDV Sterile Safety Needle | QNS | 2021-02-16 | 0 |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | QNQ | 2021-02-16 | 0 |
| K192222 | EZ-Inject Single use Needle | FMI | 2020-05-12 | 270 |
| K172483 | Kopac Sterile Needle | FMI | 2018-06-21 | 309 |
Recalls
openFDA lists no recalls under a recalling firm named Poonglim Pharmatech, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Poonglim Pharmatech, Inc. have?
Poonglim Pharmatech, Inc. has 6 FDA 510(k) clearances (first 2018, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear Poonglim Pharmatech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Poonglim Pharmatech, Inc.'s cleared 510(k)s is 150 days. Since 2017: 150 days, versus 164 days for all cleared 510(k)s in the same product codes.
What devices does Poonglim Pharmatech, Inc. make?
Its most frequent FDA product codes are QNQ (Low Dead Space Piston Syringe, 3); FMI (Needle, Hypodermic, Single Lumen, 2); QNS (Low Dead Space Needle, Single Lumen, Hypodermic, 1).
Has Poonglim Pharmatech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Poonglim Pharmatech, Inc. Related entities may recall under other names.
Next steps
- See all 6 Poonglim Pharmatech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QNQ, Poonglim Pharmatech, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.