Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kub Technologies, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
339 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210955 | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | 2021-09-20 | 174 | 0 |
| K210956 | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | 2021-08-31 | 154 | 0 |
| K210957 | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | 2021-08-31 | 154 | 0 |
| K200756 | Kubtec Mozart Supra | Kub Technologies, Inc. | 2020-06-12 | 80 | 0 |
| K183624 | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | 2019-06-20 | 176 | 0 |
| K151221 | Kubtec DIGIVIEW 395 | Kub Technologies, Inc. | 2015-06-23 | 47 | 0 |
| K141539 | KUBTEC X250 | Kub Technologies, Inc. | 2014-10-29 | 141 | 0 |
| K103348 | DIGIVIEW 250 | Kub Technologies, Inc. | 2011-10-20 | 339 | 0 |
| K083510 | KUBTEC XPERT 20 | Kub Technologies, Inc. | 2009-01-08 | 43 | 0 |
| K071233 | XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM | Kub Technologies, Inc. | 2007-06-20 | 48 | 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