510(k) Report

FDA applicant

Embryotech Laboratories, Inc.

Wayland, MA2 decisions1998–20010 recalls

FDA records 2 decisions for Embryotech Laboratories, Inc. (Wayland, MA) from 1998 to 2001: 2 510(k) clearances. All are in product code POV (Semen Analysis Device). Its devices cite 2 predicates, 1 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Embryotech Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Embryotech Laboratories, 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?

  • POVSemen Analysis Device2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K011679Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 20013cite it
  • K983473Fertilmarq Test KitEmbryotech Laboratories, Inc. · 19981cites it

What has FDA decided for it lately?

  • K011679Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc. · 2001
  • K983473Fertilmarq Test KitEmbryotech Laboratories, Inc. · 1998

All 2 as Embryotech Laboratories, Inc. →