510(k) Report

FDA applicant

Awareness Technology, Inc.

Palm City, FL18 decisions1985–20180 recalls

FDA records 18 decisions for Awareness Technology, Inc. (Palm City, FL) from 1985 to 2018: 18 510(k) clearances. Most are in product codes JJQ (Colorimeter, Photometer, Spectrophotometer For…) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 1 predicate, 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 chemistry panel, where it files most

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

FDA decisions per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Awareness Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJQColorimeter, Photometer, Spectrophotometer For Clinical Use8decisions
  • LCPAssay, Glycosylated Hemoglobin2decisions
  • JLWRadioimmunoassay, Thyroid-Stimulating Hormone1decision
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision
  • JQWStation, Pipetting And Diluting, For Clinical Use1decision
  • CIXBromcresol Green Dye-Binding, Albumin1decision

Also: JGS (1), JFS (1), JJY (1), KHG (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K861697Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 19863cite it

What has FDA decided for it lately?

  • K171476SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc. · 2018
  • K013420Chemwell, Also Known as Project 2900Awareness Technology, Inc. · 2002
  • K010877Chemwell, Model 2900Awareness Technology, Inc. · 2001
  • K974762Stat TracksAwareness Technology, Inc. · 1998
  • K943729Dye Check Strips 545-630Awareness Technology, Inc. · 1994
  • K941394Stat Fax 2600Awareness Technology, Inc. · 1994
  • K923598Redi-Check Photmeter Q.a.Awareness Technology, Inc. · 1992
  • K900224Stat Fax (TM)-2100Awareness Technology, Inc. · 1990

All 18 as Awareness Technology, Inc. →