510(k) Report

FDA applicant

3B Products, LLC

Lake Wales, FL3 decisions2011–20121 recall

FDA records 3 decisions for 3B Products, LLC (Lake Wales, FL) from 2011 to 2012: 3 510(k) clearances. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “3B Products, Inc.”.

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 3B Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2011: 12012: 2
2011high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2011high 1 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — 3B Products, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3B Products, 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

Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc. · 20122cite it
  • K1122713B Willow3B Products, LLC · 20121cites it

What has FDA decided for it lately?

  • K110629Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc. · 2012
  • K1122713B Willow3B Products, LLC · 20121 recall
  • K1034343B Flex-Lite3B Products, LLC · 2011

All 2 as 3B Products, LLC →The one decision as 3B Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K112271Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number…Jun 15, 2023Class II