FDA applicant

Biomerics Nle

Brooklyn Park, MN2 decisions2023–20240 recalls

FDA records 2 decisions for Biomerics Nle (Brooklyn Park, MN) from 2023 to 2024: 2 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). Its devices cite 2 predicates, 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Biomerics Nle by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biomerics Nle’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 “Biomerics”

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

Biomerics 2

Biomerics Nle

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Biomerics”