510(k) Report

FDA applicant

Nascor Pty., Ltd.

Sydney, Australia, AU2 decisions1991–19940 recalls

FDA records 2 decisions for Nascor Pty., Ltd. (Sydney, Australia, AU) from 1991 to 1994: 2 510(k) clearances. All are in product code BYL (Tent, Oxygen). 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, anesthesiology panel, where it files most

How often FDA has decided Nascor Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nascor Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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