Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Curvebeam, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
131 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241713 | HiRise (1040-230) | Curvebeam, LLC | 2024-07-12 | 28 | 0 |
| K203187 | HiRise | Curvebeam, LLC | 2020-11-18 | 22 | 0 |
| K181962 | CubeVue | Curvebeam, LLC | 2018-08-07 | 15 | 0 |
| K180727 | LineUp | Curvebeam, LLC | 2018-05-11 | 52 | 0 |
| K170789 | In Reach | Curvebeam, LLC | 2017-05-05 | 50 | 0 |
| K113548 | PEDCAT | Curvebeam, LLC | 2012-04-10 | 131 | 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