FDA applicant

Regulatory Insight, Inc.

Littleton, CO4 decisions2002–20140 recalls

FDA records 4 decisions for Regulatory Insight, Inc. (Littleton, CO) from 2002 to 2014: 4 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and HIR (Perineometer). Its devices cite 1 predicate, 0 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, physical medicine panel, where it files most

How often FDA has decided Regulatory Insight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Regulatory Insight, 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 “Regulatory”

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

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

Regulatory Insight, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Regulatory”