Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cortechs Labs, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
245 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241098 | NeuroQuant | Cortechs Labs, Inc. | 2024-08-22 | 122 | 0 |
| K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021-11-19 | 245 | 0 |
| K170981 | NeuroQuant | Cortechs Labs, Inc. | 2017-09-07 | 157 | 0 |
| K061855 | NEUROQUANT | Cortechs Labs, Inc. | 2006-08-10 | 41 | 0 |
| K032186 | AUTOALIGN | Cortechs Labs, Inc. | 2003-10-14 | 89 | 0 |
| K021191 | AUTOALIGN | Cortechs Labs, Inc. | 2002-07-12 | 88 | 0 |
| K012563 | DEEP GRAY | Cortechs Labs, Inc. | 2001-11-02 | 85 | 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