Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Air Techniques, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
280 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | 2019-08-21 | 64 | 0 |
| K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | 2019-07-26 | 106 | 0 |
| K101289 | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-F | Air Techniques, Inc. | 2010-08-03 | 88 | 0 |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Air Techniques, Inc. | 2009-08-18 | 207 | 0 |
| K052271 | RINSENDO | Air Techniques, Inc. | 2006-05-26 | 280 | 0 |
| K050693 | ACCENT | Air Techniques, Inc. | 2005-05-26 | 70 | 0 |
| K042397 | SCANX 14 | Air Techniques, Inc. | 2004-10-05 | 33 | 0 |
| K042266 | ACCLAIM | Air Techniques, Inc. | 2004-08-31 | 8 | 0 |
| K031198 | SCANX 10 | Air Techniques, Inc. | 2003-06-20 | 65 | 0 |
| K024285 | A/T X-RAY 70 | Air Techniques, Inc. | 2003-04-16 | 114 | 0 |
| K013893 | SCANX | Air Techniques, Inc. | 2002-02-01 | 70 | 0 |
| K002122 | VECTOR | Air Techniques, Inc. | 2000-12-21 | 161 | 0 |
| K984584 | AIR TECHNIQUES' DENTO-VAC | Air Techniques, Inc. | 1999-03-22 | 88 | 0 |
| K981564 | AIR TECHNIQUES' AIRDENT II | Air Techniques, Inc. | 1998-09-24 | 146 | 0 |
| K982615 | AIRDENT RADIANCE CURING LIGHT | Air Techniques, Inc. | 1998-08-24 | 28 | 0 |
| K974204 | VISTACAM OMNI AND VIASTCAM OMNI (IC) | Air Techniques, Inc. | 1998-01-08 | 59 | 0 |
| K942698 | VACSTAR | Air Techniques, Inc. | 1995-03-17 | 282 | 0 |
| K943204 | VISTACAM | Air Techniques, Inc. | 1995-03-16 | 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