Calnor of EL Paseo, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Calnor of EL Paseo, Inc.” (first 1977, latest 1984), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | 5 | 5 |
| FLE | Sterilizer, Steam | 1 | 1 |
Review panels
- Neurology (5)
- General Hospital (1)
Most recent Calnor of EL Paseo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842354 | EMG MODEL 133 | HCC | 1984-07-17 | 71 |
| K842353 | TEMPERATURE 132 | HCC | 1984-07-17 | 71 |
| K842288 | EEG 130 | HCC | 1984-07-17 | 71 |
| K841895 | GSR, 126, EEG 130-TEMP. 132, EMG 133 | HCC | 1984-07-17 | 71 |
| K834152 | ETHYLENE OXIDE DETECTOR GLD-1-07 | FLE | 1984-03-19 | 109 |
| K771577 | CLINICAL EMG MODEL 133 | HCC | 1977-08-26 | 8 |
Recalls
openFDA lists no recalls under a recalling firm named Calnor of EL Paseo, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Calnor of EL Paseo, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Calnor of EL Paseo, Inc.” (first 1977, latest 1984), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Calnor of EL Paseo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Calnor of EL Paseo, Inc. is 71 days.
Which FDA product codes appear under Calnor of EL Paseo, Inc.?
The most frequent FDA product codes under this applicant name are HCC (Device, Biofeedback, 5); FLE (Sterilizer, Steam, 1).
Next steps
- See all 6 Calnor of EL Paseo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCC, Calnor of EL Paseo, 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.