Vega Technologies, Inc.: FDA filings under this applicant name

FDA lists 6 510(k) clearances under the applicant name “Vega Technologies, Inc.” (first 2001, latest 2011), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 128 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

YearClearancesMedian review days
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Top product codes

Product codeDeviceSubmissions510(k) clearances
FLLContinuous Measurement Thermometer22
BTICompressor, Air, Portable11
BZDVentilator, Non-Continuous (Respirator)11
CAFNebulizer (Direct Patient Interface)11
JCXApparatus, Suction, Ward Use, Portable, Ac-Powered11

Review panels

Most recent Vega Technologies, Inc. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K102625VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03BZD2011-06-10270
K102934INFRARED EAR THERMOMETER, MODEL IR-04MTFLL2011-01-14102
K102626VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01JCX2010-11-1260
K041516DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9FLL2004-09-0896
K031413VIGORMIST COMPRESSOR NEBULIZERBTI2003-10-07155
K002831VEGA ULTRASONIC NEBULIZERCAF2001-05-23254

Recalls

openFDA lists no recalls under a recalling firm named Vega Technologies, Inc..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Vega Technologies, Inc. (a text match, not an official crosswalk):

Frequently asked questions

How many FDA 510(k) clearances are listed under Vega Technologies, Inc.?

FDA lists 6 510(k) clearances under the applicant name “Vega Technologies, Inc.” (first 2001, latest 2011), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Vega Technologies, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Vega Technologies, Inc. is 128 days.

Which FDA product codes appear under Vega Technologies, Inc.?

The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 2); BTI (Compressor, Air, Portable, 1); BZD (Ventilator, Non-Continuous (Respirator), 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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