510(k) Report

FDA applicant

Genexel-Sein, Inc.

Roswell, GA2 decisions2007–20090 recalls

FDA records 2 decisions for Genexel-Sein, Inc. (Roswell, GA) from 2007 to 2009: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and NBW (System, Test, Blood Glucose, 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, cardiovascular panel, where it files most

How often FDA has decided Genexel-Sein, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Genexel-Sein, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • NBWSystem, Test, Blood Glucose, 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?

  • K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009
  • K071523Full Auto Wrist Digital Blood Pressure Monitor, Models BP1600, BP1650, BP1700 and BP1750Genexel-Sein, Inc. · 2007

All 2 as Genexel-Sein, Inc. →

Other applicant names beginning “Genexel-Sein”

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

Genexel Medical Instrument, Inc. 1