510(k) Report

FDA applicant

Amnisure International, LLC

Cambridge, MA1 decision2009–20092 recalls

FDA records 1 decision for Amnisure International, LLC (Cambridge, MA) in 2009: 1 510(k) clearance. All are in product code NQM (Immunoassay For Detection Of Amniotic Fluid…). 2 recalls are linked to its devices, 1 Class I.

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 Amnisure International, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2020

2018: 1, 1 Class I2020: 1
2009high 1 (2018) · low 0 (2009)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • NQMImmunoassay For Detection Of Amniotic Fluid Protein (S).1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K081767Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 20091cites it

What has FDA decided for it lately?

  • K081767Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 20091 Class I recall

The one decision as Amnisure International, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K081767AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)…Feb 21, 2020Class II
  • K081767AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog…May 18, 2018Class I