510(k) Report

FDA applicant

Abmrc, LLC

Eagan, MN4 decisions2020–20260 recalls

FDA records 4 decisions for Abmrc, LLC (Eagan, MN) from 2020 to 2026: 4 510(k) clearances. All are in product code NHJ (Device, Positive Pressure Breathing…). Its devices cite 4 predicates, 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2024

2020: 12022: 12024: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

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Which product codes does it file in?

  • NHJDevice, Positive Pressure Breathing, Intermittent4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231728BiWaze Clear SystemAbmrc, LLC · 20241cites it

What has FDA decided for it lately?

  • K260604BiWaze Clear SystemAbmrc, LLC · 2026
  • K231728BiWaze Clear SystemAbmrc, LLC · 2024
  • K213564BiWaze Clear SystemAbmrc, LLC · 2022
  • K191912BiWaze CoughAbmrc, LLC · 2020

All 4 as Abmrc, LLC →