Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QBC — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
344 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253587 | Cala kIQ Plus | Cala Health, Inc. | 2026-03-17 | 120 | 0 |
| K251517 | Encora X1 | Encora, Inc. | 2026-02-05 | 265 | 0 |
| K250096 | Felix NeuroAI System | Fasikl Incorporated | 2025-07-01 | 168 | 0 |
| K243848 | Cala kIQ | Cala Health, Inc. | 2025-01-16 | 31 | 0 |
| K242259 | Cala kIQ | Cala Health, Inc. | 2024-11-22 | 114 | 0 |
| K222237 | Cala kIQ | Cala Health, Inc. | 2022-11-22 | 119 | 0 |
| K203288 | Cala Trio | Cala Health, Inc. | 2021-10-05 | 330 | 0 |
| K182706 | External upper limb tremor stimulator | Cala Health, Inc. | 2018-10-25 | 28 | 0 |
| DEN170028 | Cala ONE | Cala Health, Inc. | 2018-04-26 | 344 | 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