510(k) Report

FDA applicant

Htl-Strefa S.A

Ozorkow, PL7 decisions2015–20250 recalls

FDA records 7 decisions for Htl-Strefa S.A (Ozorkow, PL) from 2015 to 2025: 7 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMK (Single Use Only Blood Lancet With An Integral…). Since 2016 its 510(k)s took a median of 253 days from receipt to decision, against 253 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 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 Htl-Strefa S.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12017: 12018: 12020: 22022: 12025: 1
2015high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Htl-Strefa S.A by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen5decisions
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision
  • QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 253 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 253 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 2 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.

  • K171982Droplet Pen NeedleHtl-Strefa S.A · 20183cite it
  • K170988DropSafe Safety Pen NeedleHtl-Strefa S.A · 20173cite it
  • K192082Droplet Pen Needle 34GHtl-Strefa S.A · 20202cite it
  • K143437Droplet Pen NeedlesHtl-Strefa S.A · 20151cites it

What has FDA decided for it lately?

  • K250016droplet® personal lancetsHtl-Strefa S.A · 2025
  • K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety…Htl-Strefa S.A · 2022
  • K202340Droplet Pen Needle 30G & 33GHtl-Strefa S.A · 2020
  • K192082Droplet Pen Needle 34GHtl-Strefa S.A · 2020
  • K171982Droplet Pen NeedleHtl-Strefa S.A · 2018
  • K170988DropSafe Safety Pen NeedleHtl-Strefa S.A · 2017
  • K143437Droplet Pen NeedlesHtl-Strefa S.A · 2015

All 7 as Htl-Strefa S.A →