510(k) Report

FDA applicant

Dana Products, Inc.

South Barrington, IL9 decisions2002–20140 recalls

FDA records 9 decisions for Dana Products, Inc. (South Barrington, IL) from 2002 to 2014: 9 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). 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 Dana Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 22011: 32013: 22014: 1
2007high 3 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dana 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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Other applicant names beginning “Dana”

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