510(k) Report

FDA applicant

Poonglim Pharmatech, Inc.

Gunsan, KR6 decisions2018–20240 recalls

FDA records 6 decisions for Poonglim Pharmatech, Inc. (Gunsan, KR) from 2018 to 2024: 6 510(k) clearances. Most are in product codes QNQ (Low Dead Space Piston Syringe) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 270 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Poonglim Pharmatech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12020: 12021: 22023: 12024: 1
2018high 2 (2021) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Poonglim Pharmatech, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Poonglim Pharmatech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QNQLow Dead Space Piston Syringe3decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • QNSLow Dead Space Needle, Single Lumen, Hypodermic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 270 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 20215cite it
  • K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 20215cite it
  • K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile…Poonglim Pharmatech, Inc. · 20231cites it
  • K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 20201cites it
  • K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 20181cites it

What has FDA decided for it lately?

  • K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile…Poonglim Pharmatech, Inc. · 2024
  • K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile…Poonglim Pharmatech, Inc. · 2023
  • K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
  • K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. · 2021
  • K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc. · 2020
  • K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc. · 2018

All 6 as Poonglim Pharmatech, Inc. →