Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosonics, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882555 | ANOTRON(R) INCONTINENCE CONTROL SYSTEM | Biosonics, Inc. | 1988-08-30 | 70 | 0 |
| K864448 | THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM) | Biosonics, Inc. | 1987-02-06 | 86 | 0 |
| K862683 | BIOSOICS SPHINCTER TRAINING SYSTEM | Biosonics, Inc. | 1986-11-12 | 120 | 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