Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ulab Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K211510 | uLab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2022-02-24 | 286 | 0 |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | 2020-06-23 | 90 | 0 |
| K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | 2020-02-11 | 144 | 0 |
| K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | 2018-01-09 | 252 | 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