Medical Data Electronics: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Medical Data Electronics” (first 1985, latest 2002), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 3 | 3 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (21)
- Anesthesiology (5)
- General Hospital (1)
Most recent Medical Data Electronics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014294 | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 | DQA | 2002-01-25 | 28 |
| K012336 | MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 | DSI | 2001-10-03 | 71 |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | DRO | 2000-03-28 | 29 |
| K992413 | ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR | DRT | 1999-08-19 | 30 |
| K992411 | ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR | DRT | 1999-08-18 | 29 |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | MLD | 1998-11-25 | 163 |
| K970763 | MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR | DQA | 1997-07-14 | 133 |
| K970011 | ESCORT II CLINICAL THERMOMETRY MODULE (CTM) | FLL | 1997-07-09 | 188 |
| K970012 | ESCORT LINK CENTRAL STATION MONITOR | DSI | 1997-06-26 | 175 |
| K961138 | ESORT II + 400 SERIES MONITOR | DRO | 1996-12-10 | 264 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Data Electronics.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
- Medical Instrument Development Laboratories, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Data Electronics?
FDA lists 27 510(k) clearances under the applicant name “Medical Data Electronics” (first 1985, latest 2002), across 13 product codes in 3 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 Medical Data Electronics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Data Electronics is 92 days.
Which FDA product codes appear under Medical Data Electronics?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 3).
Next steps
- See all 27 Medical Data Electronics clearances with predicates and recalls
- Run predicate analysis for product code DQA, Medical Data Electronics'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.