510(k) Report

FDA applicant

D R Burton Healthcare, LLC

Farmville, NC2 decisions2016–20200 recalls

FDA records 2 decisions for D R Burton Healthcare, LLC (Farmville, NC) from 2016 to 2020: 2 510(k) clearances. All are in product code BWF (Spirometer, Therapeutic (Incentive)). Its devices cite 4 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, anesthesiology panel, where it files most

How often FDA has decided D R Burton Healthcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12020: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — D R Burton Healthcare, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BWFSpirometer, Therapeutic (Incentive)2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K192000D R Burton OxyPAPD R Burton Healthcare, LLC · 2020
  • K160636iPEP System and vPEPD R Burton Healthcare, LLC · 2016

All 2 as D R Burton Healthcare, LLC →