FDA applicant

Philosys, Inc.

New York, NY5 decisions2013–20150 recalls

FDA records 5 decisions for Philosys, Inc. (New York, NY) from 2013 to 2015: 5 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and CGA (Glucose Oxidase, Glucose). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

3in 2015

2013high 3 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Philosys, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philosys, Inc.’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

Philosys, Inc.

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?