Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Whs Products, 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) |
|---|---|---|---|---|---|
| K834088 | GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING | Whs Products, Inc. | 1983-12-15 | 92 | 0 |
| K833172 | ECG-GEL ELECTRODE GEL | Whs Products, Inc. | 1983-11-21 | 66 | 0 |
| K828673 | RICH-MAR ULTRASOUND COUPLING LOTION | Whs Products, Inc. | 1983-01-19 | 64 | 0 |
| K827885 | BIO-DERM COUPLING LOTION | Whs Products, Inc. | 1982-01-29 | 28 | 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