510(k) Report

FDA applicant

Altana, Inc.

Melville, NY2 decisions1988–19940 recalls

FDA records 2 decisions for Altana, Inc. (Melville, NY) from 1988 to 1994: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and DAN (Fibrinopeptide A, Antigen, Antiserum, Control). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Altana, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Altana, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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