Electronics For Medicine, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Electronics For Medicine, Inc.” (first 1977, latest 1983), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 31 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| BZC | Calculator, Pulmonary Function Data | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DRR | Amplifier And Signal Conditioner, Biopotential | 1 | 1 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (3)
Most recent Electronics For Medicine, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830791 | UNIVERSAL MEDDARS SYSTEM | DPS | 1983-06-22 | 100 |
| K830795 | CABINET FOR MULTIPLE FUNCTION BLOCKS | DRT | 1983-05-18 | 65 |
| K792528 | RESPIRATION/APNEA AMPLIFIER MODEL 3105 | BZQ | 1980-02-21 | 76 |
| K791006 | SMART BILECTRODES | DRX | 1979-06-11 | 11 |
| K790198 | MONITOR PLUG-IN MODEL M1106 ECG | DRT | 1979-03-06 | 40 |
| K790203 | INTERVAL TIMER MODEL V4295 | DRR | 1979-03-02 | 31 |
| K790185 | MODEL V 4207 INTEGRATING PLUG-IN | BZC | 1979-02-16 | 18 |
| K780107 | ANALYZER-PLUG-IN, CO2 MODEL M 3104 | CCK | 1978-01-30 | 11 |
| K770366 | ISOLATED ELECTROCARDIOGRAPH MODEL 1207 | DPS | 1977-03-01 | 6 |
Recalls
openFDA lists no recalls under a recalling firm named Electronics For Medicine, 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.
- Electronics Research & Production (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electronics For Medicine, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Electronics For Medicine, Inc.” (first 1977, latest 1983), across 7 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 Electronics For Medicine, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electronics For Medicine, Inc. is 31 days.
Which FDA product codes appear under Electronics For Medicine, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); BZC (Calculator, Pulmonary Function Data, 1).
Next steps
- See all 9 Electronics For Medicine, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Electronics For Medicine, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.