510(k) Report

FDA applicant

3B Medical, Inc.

Lake Wales, FL10 decisions2013–20220 recalls

FDA records 10 decisions for 3B Medical, Inc. (Lake Wales, FL) from 2013 to 2022: 10 510(k) clearances. Most are in product codes BZD (Ventilator, Non-Continuous (Respirator)) and CAW (Generator, Oxygen, Portable). Since 2016 its 510(k)s took a median of 248 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 5 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 3B Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2013: 32014: 12015: 12016: 22020: 12021: 12022: 1
2013high 3 (2013) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — 3B Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3B Medical, Inc.’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)9decisions
  • CAWGenerator, Oxygen, Portable1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 248 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 217 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K153387Luna CPAP and Auto CPAP System3B Medical, Inc. · 20162cite it
  • K201620Luna® G3 BPAP 25A3B Medical, Inc. · 20212cite it
  • K1317073B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap Systems3B Medical, Inc. · 20131cites it
  • K1329673B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc. · 20131cites it
  • K141770Luna Cpap and Auto-Cpap System3B Medical, Inc. · 20151cites it
  • K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc. · 20141cites it

What has FDA decided for it lately?

  • K212263Luna G3 BPAP System3B Medical, Inc. · 2022
  • K201620Luna® G3 BPAP 25A3B Medical, Inc. · 2021
  • K200496Aer X3B Medical, Inc. · 2020
  • K160127iCodeConnect3B Medical, Inc. · 2016
  • K153387Luna CPAP and Auto CPAP System3B Medical, Inc. · 2016
  • K141770Luna Cpap and Auto-Cpap System3B Medical, Inc. · 2015
  • K1337693B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc. · 2014
  • K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013

All 10 as 3B Medical, Inc. →