510(k) Report

FDA applicant

Atlas Medical

Amman, JO2 decisions2011–20190 recalls

FDA records 2 decisions for Atlas Medical (Amman, JO) from 2011 to 2019: 2 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 2 predicates, 0 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, clinical toxicology panel, where it files most

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

FDA decisions per year

1in 2019

2011: 12019: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Atlas Medical by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine1decision
  • LCXKit, Test, Pregnancy, Hcg, Over The Counter1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical · 2019
  • K102760Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical · 2011

All 2 as Atlas Medical →

Other applicant names beginning “Atlas”

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

Atlas Spine, Inc. 19Atlas Researches, Ltd. 4Atlas Medical Products, Inc. 1Atlas Technology 1Atlas Surgical Belt Co., Inc. 1Atlas Link Technology Co., Ltd. 1