FDA applicant

Hyperfine, Inc.

Guilforf, CT14 decisions2021–20260 recalls

FDA records 14 decisions for Hyperfine, Inc. (Guilforf, CT) from 2021 to 2026: 14 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 37 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 12 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 Hyperfine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2021high 5 (2022) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Hyperfine, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hyperfine, 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 “Hyperfine”

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

Hyperfine Research, Inc. 3

Hyperfine, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hyperfine”