510(k) Report

FDA applicant

Vega Technologies, Inc.

Taipei, TW6 decisions2001–20112 recalls

FDA records 6 decisions for Vega Technologies, Inc. (Taipei, TW) from 2001 to 2011: 6 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 6 predicates, 1 of them its own earlier devices. 2 recalls are 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 Vega Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2010: 12011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2011: 12015: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vega Technologies, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vega Technologies, 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?

  • FLLContinuous Measurement Thermometer2decisions
  • BZDVentilator, Non-Continuous (Respirator)1decision
  • CAFNebulizer (Direct Patient Interface)1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision
  • BTICompressor, Air, Portable1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K002831Vega Ultrasonic NebulizerVega Technologies, Inc. · 20011cites it
  • K031413Vigormist Compressor NebulizerVega Technologies, Inc. · 20031cites it

What has FDA decided for it lately?

  • K102625Vega Cpap System/Heated Humidifier, Model CP-03Vega Technologies, Inc. · 2011
  • K102934Infrared Ear Thermometer, Model IR-04MTVega Technologies, Inc. · 2011
  • K102626Vega Medical Suction Equipment, Model SU-01/SU-DC01Vega Technologies, Inc. · 2010
  • K041516Digital Thermometer, Models MT-XX8 and MT-XX9Vega Technologies, Inc. · 20041 recall
  • K031413Vigormist Compressor NebulizerVega Technologies, Inc. · 20031 recall
  • K002831Vega Ultrasonic NebulizerVega Technologies, Inc. · 2001

All 6 as Vega Technologies, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K031413Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy…Apr 20, 2015Class II
  • K041516Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model…Nov 23, 2011