Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LQK — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
131 daysmedian FDA review time
308 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221046 | Invu by Nuvo | Nuvo- Group , Ltd. | 2022-05-06 | 28 | 0 |
| K210025 | INVU by Nuvo | Nuvo- Group , Ltd. | 2021-05-28 | 144 | 0 |
| K191401 | PregSense | Nuvo- Group , Ltd. | 2020-03-27 | 308 | 0 |
| K143114 | Sense4Baby System Model B+ (MSA) | Airstrip Technologies, Inc. | 2015-03-10 | 131 | 1 |
| K020390 | MODIFICATION TO FETAL ASSIST | Huntleigh Diagnostics , Ltd. | 2002-04-19 | 72 | 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