Electromedics, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Electromedics, Inc.” (first 1977, latest 1994), across 18 product codes in 6 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 10 | 10 |
| CAC | Apparatus, Autotransfusion | 7 | 7 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 5 | 5 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 3 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 2 |
| BYZ | Trap, Sterile Specimen | 1 | 1 |
| BZW | Stethoscope, Esophageal | 1 | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 | 1 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
Plus 8 more product codes.
Review panels
- Cardiovascular (24)
- General Hospital (12)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Electromedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934964 | ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR | FLL | 1994-03-07 | 143 |
| K933832 | ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR | FLL | 1994-01-28 | 176 |
| K934355 | ELECTROMEDICS BLOOD HEAT EXCHANGER | DTR | 1993-12-03 | 87 |
| K930154 | EL2-SERIES BLOOD COLLECTION REERVOIR | DTN | 1993-07-01 | 169 |
| K926250 | ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR | DTN | 1993-02-19 | 67 |
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | BYZ | 1993-02-05 | 102 |
| K915737 | AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR | DTN | 1992-09-03 | 258 |
| K910238 | PORTABLE AUTO TRANSFUSION SYSTEM 500 | CAC | 1991-06-19 | 152 |
| K910935 | MODIFIED PYROGEN TESTING | DTM | 1991-05-16 | 91 |
| K902723 | ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 | DTM | 1990-12-13 | 177 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electromedics, 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.
- Electromedics Co. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electromedics, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Electromedics, Inc.” (first 1977, latest 1994), across 18 product codes in 6 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 Electromedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electromedics, Inc. is 78 days.
Which FDA product codes appear under Electromedics, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 10); CAC (Apparatus, Autotransfusion, 7); DTN (Reservoir, Blood, Cardiopulmonary Bypass, 5).
Next steps
- See all 41 Electromedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Electromedics, 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.