FDA applicant

Phase One Disign Co.

San Rafael, CA1 decision1986–19860 recalls

FDA records 1 decision for Phase One Disign Co. (San Rafael, CA) in 1986: 1 510(k) clearance. All are in product code EAK (Screen, Leaded, Operator Radiation Protector). 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 Phase One Disign Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Phase One Disign Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Phase One Disign Co.’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 “Phase”

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

Phase-R Corp. 1 Phase Medical, Inc. 1 Phase Medical Systems, Inc. 1 Phase One Medical 1 Phase I Corp. 1 Phase Change 1

Phase One Disign Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Phase”