Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hayes Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
76 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K790883 | STRESS/EMERGENCY EELCTRODE | Hayes Products, Inc. | 1979-07-24 | 76 | 0 |
| K791139 | PREGELLED DISPOSABLE ECG ELECTRODES | Hayes Products, Inc. | 1979-07-10 | 22 | 0 |
| K791140 | PREGELLED DISPOSABLE EELCTRO. SERIES 600 | Hayes Products, Inc. | 1979-07-10 | 22 | 0 |
| K781940 | EKG ELECTRODES, DISPOSABLE | Hayes Products, Inc. | 1978-11-29 | 9 | 0 |
| K771447 | PREGELLED DISP. EKG MONITORING ELECT- | Hayes Products, Inc. | 1977-08-04 | 2 | 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