510(k) Report

FDA applicant

Agamatrix, Inc.

Salem, NH14 decisions2006–20240 recalls

FDA records 14 decisions for Agamatrix, Inc. (Salem, NH) from 2006 to 2024: 14 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 233 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Agamatrix”.

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 Agamatrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 32008: 12009: 12010: 12011: 12013: 22016: 22024: 1
2007high 3 (2007) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Agamatrix, Inc.’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?

  • NBWSystem, Test, Blood Glucose, Over The Counter14decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 233 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 9 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.

  • K052762Liberty Blood Glucose Monitoring System, Model 8000-0067Agamatrix, Inc. · 20064cite it
  • K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc. · 20113cite it
  • K062434Zero-Click Data Management System, Model 8000-01528Agamatrix · 20062cite it
  • K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 20102cite it
  • K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 20161cites it
  • K072413Modification to: Jazz Blood Glucose Monitoring SystemAgamatrix · 20071cites it

What has FDA decided for it lately?

  • K241304WaveSense Jazz Blood Glucose Monitoring SystemAgamatrix · 2024
  • K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
  • K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc. · 2016
  • K132821Agamatrix Health ManagerAgamatrix, Inc. · 2013
  • K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc. · 2013
  • K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc. · 2011
  • K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
  • K083265Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381Agamatrix, Inc. · 2009

All 7 as Agamatrix, Inc. →All 7 as Agamatrix →