Hayes Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hayes Products, Inc.” (first 1977, latest 1979), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 22 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 4 | 4 |
Plus 1 more product codes.
Review panels
- Cardiovascular (4)
Most recent Hayes Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K790883 | STRESS/EMERGENCY EELCTRODE | — | 1979-07-24 | 76 |
| K791140 | PREGELLED DISPOSABLE EELCTRO. SERIES 600 | DRX | 1979-07-10 | 22 |
| K791139 | PREGELLED DISPOSABLE ECG ELECTRODES | DRX | 1979-07-10 | 22 |
| K781940 | EKG ELECTRODES, DISPOSABLE | DRX | 1978-11-29 | 9 |
| K771447 | PREGELLED DISP. EKG MONITORING ELECT- | DRX | 1977-08-04 | 2 |
Recalls
openFDA lists no recalls under a recalling firm named Hayes Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hayes Medical, Inc. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hayes Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Hayes Products, Inc.” (first 1977, latest 1979), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hayes Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hayes Products, Inc. is 22 days.
Which FDA product codes appear under Hayes Products, Inc.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 4).
Next steps
- See all 5 Hayes Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Hayes Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.