FDA applicant

Pearl, Inc.

Beverly Hills, CA8 decisions2022–20250 recalls

FDA records 8 decisions for Pearl, Inc. (Beverly Hills, CA) from 2022 to 2025: 8 510(k) clearances. Most are in product codes MYN (Analyzer, Medical Image) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 210 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 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, radiology panel, where it files most

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

FDA decisions per year

7in 2025

2022high 7 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Pearl, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pearl, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Pearl”

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

Pearl Instruments Corp. 2 Pearl Diagnostics, Inc. 1 Pearl Digital, Inc. 1

Pearl, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pearl”