510(k) Report

FDA applicant

Obmedical Company

Gainesville, FL2 decisions2015–20200 recalls

FDA records 2 decisions for Obmedical Company (Gainesville, FL) from 2015 to 2020: 2 510(k) clearances. All are in product code OSP (Uterine Electromyographic Monitor). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Obmedical Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Obmedical Company by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OSPUterine Electromyographic Monitor2decisions

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142583LaborView LV1000Obmedical Company · 20151cites it

What has FDA decided for it lately?

  • K190798LaborView™ LV1000 Wireless Electrode SystemObmedical Company · 2020
  • K142583LaborView LV1000Obmedical Company · 2015

All 2 as Obmedical Company →