FDA applicant

Pulmonary Filtration Technologies, LLC

Bonita Springs, FL1 decision2009–20090 recalls

FDA records 1 decision for Pulmonary Filtration Technologies, LLC (Bonita Springs, FL) in 2009: 1 510(k) clearance. All are in product code BZG (Spirometer, Diagnostic). 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Pulmonary Filtration Technologies, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pulmonary Filtration Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Pulmonary”

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

Pulmonary Testing Systems 3 Pulmonary Data Services, Inc. 1 Pulmonary Data Services Inst., Inc. 1 Pulmonary Medical Devices, Inc. 1

Pulmonary Filtration Technologies, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Pulmonary”