510(k) Report

FDA applicant

Bio Medical Technologies Co., Ltd.

Dunwoody, GA2 decisions2009–20140 recalls

FDA records 2 decisions for Bio Medical Technologies Co., Ltd. (Dunwoody, GA) from 2009 to 2014: 2 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 3 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, cardiovascular panel, where it files most

How often FDA has decided Bio Medical Technologies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009: 12014: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Bio Medical Technologies Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio Medical Technologies Co., Ltd.’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?

  • DQAOximeter2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd. · 2014
  • K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd. · 2009

All 2 as Bio Medical Technologies Co., Ltd. →