Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Poonglim Pharmatech, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
270 daysmedian FDA review time
445 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLP | Poonglim Pharmatech, Inc. | 2024-05-29 | 30 | 0 |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLP | Poonglim Pharmatech, Inc. | 2023-09-15 | 445 | 0 |
| K210444 | EZ-Injec LDV Sterile Safety Needle | Poonglim Pharmatech, Inc. | 2021-02-16 | 0 | 0 |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021-02-16 | 0 | 0 |
| K192222 | EZ-Inject Single use Needle | Poonglim Pharmatech, Inc. | 2020-05-12 | 270 | 0 |
| K172483 | Kopac Sterile Needle | Poonglim Pharmatech, Inc. | 2018-06-21 | 309 | 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