510(k) Report

FDA applicant

Circle Rubber Corp.

Newark, NJ5 decisions1982–19890 recalls

FDA records 5 decisions for Circle Rubber Corp. (Newark, NJ) from 1982 to 1989: 5 510(k) clearances. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Circle Rubber Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Circle Rubber Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Circle Rubber Corp.’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 “Circle”

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