510(k) Report

FDA applicant

Stat Medical Devices

North Miami Beach, FL4 decisions2009–20230 recalls

FDA records 4 decisions for Stat Medical Devices (North Miami Beach, FL) from 2009 to 2023: 4 510(k) clearances. Most are in product codes QRK (Single Use Only Blood Lancet Without An…) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 203 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Stat Medical Devices, Inc.”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Stat Medical Devices’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2009: 12023: 3
2009high 3 (2023) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Stat Medical Devices by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stat Medical Devices’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?

  • QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature3decisions
  • FMINeedle, Hypodermic, Single Lumen1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 203 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K230310STAT Medical Device Lancing SystemStat Medical Devices · 2023
  • K222617EasyTouch Lancing DeviceStat Medical Devices · 2023
  • K223815ONE DROP Lancing DeviceStat Medical Devices · 2023
  • K092016Super-Fine Pen NeedleStat Medical Devices, Inc. · 2009

All 3 as Stat Medical Devices →The one decision as Stat Medical Devices, Inc. →

Other applicant names beginning “Stat”

FDA records each applicant name separately; these may or may not be the same firm.

Stat Medical Corp. 4Stat Path 4Stat Engineering 1Stat-Spin Technologies 1Stat Chem, Inc. 1