Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axonics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
196 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843712 | AUDIT TM V | Axonics, Inc. | 1985-04-05 | 196 | 0 |
| K833298 | AUDIT V AX 135 | Axonics, Inc. | 1983-12-01 | 69 | 0 |
| K831870 | ALLERGENETICS FLUORO-FAST READER | Axonics, Inc. | 1983-08-12 | 63 | 0 |
| K822335 | AUDIT | Axonics, Inc. | 1983-02-07 | 187 | 0 |
| K823494 | TOTAL IGE-FAST TEST | Axonics, Inc. | 1983-01-14 | 52 | 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