510(k) Report

FDA applicant

Intel Corp.

Folsom, CA3 decisions2008–20100 recalls

FDA records 3 decisions for Intel Corp. (Folsom, CA) from 2008 to 2010: 3 510(k) clearances. All are in product code DRG (Transmitters And Receivers, Physiological…). Its devices cite 6 predicates, 3 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2010

2008: 22010: 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Intel Corp. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intel 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 “Intel”

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