510(k) Report

FDA applicant

Snap Diagnostics, LLC

Wheeling, IL2 decisions2011–20240 recalls

FDA records 2 decisions for Snap Diagnostics, LLC (Wheeling, IL) from 2011 to 2024: 2 510(k) clearances. All are in product code MNR (Ventilatory Effort Recorder). Its devices cite 2 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 Snap Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2011: 12024: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Snap Diagnostics, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNRVentilatory Effort Recorder2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K110064Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 20111cites it

What has FDA decided for it lately?

  • K240100SAM Model 9-10000Snap Diagnostics, LLC · 2024
  • K110064Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 2011

All 2 as Snap Diagnostics, LLC →

Other applicant names beginning “Snap”

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

Snap Laboratories, LLC 6