Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qr S.R.L. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151612 | NewTom VGi evo | Qr S.R.L. | 2016-03-31 | 290 | 0 |
| K142222 | NewTom 5G | Qr S.R.L. | 2015-01-26 | 166 | 0 |
| K130442 | NEWTOM VGI AND NEWTOM 5G | Qr S.R.L. | 2013-07-03 | 132 | 0 |
| K110260 | NEWTOM 5G / NEWTOM 5G VERSION FP | Qr S.R.L. | 2011-04-06 | 68 | 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