510(k) Report

FDA applicant

Katena Products, Inc.

Denville, NJ3 decisions1978–19920 recalls

FDA records 3 decisions for Katena Products, Inc. (Denville, NJ) from 1978 to 1992: 3 510(k) clearances. Most are in product codes HOZ (Sponge, Ophthalmic) and HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Katena Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Katena Products, 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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