Electrocaine Medical System: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Electrocaine Medical System” (first 1980, latest 1993), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Electrocaine Medical System 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924413 | FLOWSCAN | BZG | 1993-05-06 | 248 |
| K926336 | AUDIOSCAN | EWO | 1993-03-04 | 78 |
| K844638 | ELECTROCAINE MODEL SR-IV | GZJ | 1985-01-08 | 41 |
| K830992 | XCEL MODEL XE-1 | GZJ | 1983-08-12 | 136 |
| K800317 | DAVOL EMS ADAPTER, CAT. NO. 13-7664 | GEI | 1980-03-12 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Electrocaine Medical System.
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 Electrocaine Medical System?
FDA lists 5 510(k) clearances under the applicant name “Electrocaine Medical System” (first 1980, latest 1993), across 4 product codes in 4 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 Electrocaine Medical System?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electrocaine Medical System is 78 days.
Which FDA product codes appear under Electrocaine Medical System?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); BZG (Spirometer, Diagnostic, 1); EWO (Audiometer, 1).
Next steps
- See all 5 Electrocaine Medical System clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Electrocaine Medical System'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.