Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Health Sense Intl., Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | 1996-03-12 | 112 | 0 |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | 1995-05-24 | 306 | 0 |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | 1995-05-24 | 306 | 0 |
| K911279 | DRY TIME | Health Sense Intl., Inc. | 1991-09-04 | 163 | 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