510(k) Report

FDA applicant

Oriental System Technology, Inc.

Great Neck, NY6 decisions1999–20040 recalls

FDA records 6 decisions for Oriental System Technology, Inc. (Great Neck, NY) from 1999 to 2004: 6 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 8 predicates, 2 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Oriental System Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Oriental System Technology, 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

Other applicant names beginning “Oriental”

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