FDA applicant

Regulatory Associates, Inc.

Lakewood, CO1 decision2000–20000 recalls

FDA records 1 decision for Regulatory Associates, Inc. (Lakewood, CO) in 2000: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). 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 Regulatory Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Regulatory Associates, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Regulatory”

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

Regulatory & Marketing Services, Inc. 21 Regulatory Insight, Inc. 4 Regulatory Management Services 3 Regulatory Technology Services, LLC 2 Regulatory Specialists, Inc. 1 Regulatory Consultants TO the Medical Device Indus 1 Regulatory and Marketing Services, Inc. 1 Regulatory Strategies, Inc. 1

Regulatory Associates, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Regulatory”