FDA applicant

Reflexion Medical, Inc.

Hayward, CA3 decisions2020–20251 recall

FDA records 3 decisions for Reflexion Medical, Inc. (Hayward, CA) from 2020 to 2025: 2 510(k) clearances and 1 De Novo grant. Most are in product codes QVA (Fludeoxyglucose F18-Guided Radiation Therapy…) and IYE (Accelerator, Linear, Medical). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 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 Reflexion Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2021

2020high 1 (2021) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Reflexion Medical, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Reflexion Medical, 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 “Reflexion”

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

Reflexion Health, Inc. 3

Reflexion Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Reflexion”