FDA applicant

Biospace Corporation Limited

Naples, FL10 decisions2003–20140 recalls

FDA records 10 decisions for Biospace Corporation Limited (Naples, FL) from 2003 to 2014: 10 510(k) clearances. Most are in product codes MNW (Analyzer, Body Composition) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 21 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biospace Co.,Ltd”.

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 Biospace Corporation Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 3 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biospace Corporation Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biospace Corporation Limited’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

Other applicant names beginning “Biospace”

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

Biospace Med 4

Biospace Corporation Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biospace”