Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vega Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
155 daysmedian FDA review time
270 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102625 | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 | Vega Technologies, Inc. | 2011-06-10 | 270 | 0 |
| K102934 | INFRARED EAR THERMOMETER, MODEL IR-04MT | Vega Technologies, Inc. | 2011-01-14 | 102 | 0 |
| K102626 | VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 | Vega Technologies, Inc. | 2010-11-12 | 60 | 0 |
| K041516 | DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 | Vega Technologies, Inc. | 2004-09-08 | 96 | 1 |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | 2003-10-07 | 155 | 1 |
| K002831 | VEGA ULTRASONIC NEBULIZER | Vega Technologies, Inc. | 2001-05-23 | 254 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda