Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Data Electronics — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
210 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014294 | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR | Medical Data Electronics | 2002-01-25 | 28 | 0 |
| K012336 | MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYST | Medical Data Electronics | 2001-10-03 | 71 | 0 |
| K000660 | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20 | Medical Data Electronics | 2000-03-28 | 29 | 0 |
| K992413 | ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR | Medical Data Electronics | 1999-08-19 | 30 | 0 |
| K992411 | ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR | Medical Data Electronics | 1999-08-18 | 29 | 0 |
| K982104 | ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 | Medical Data Electronics | 1998-11-25 | 163 | 0 |
| K970763 | MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II | Medical Data Electronics | 1997-07-14 | 133 | 0 |
| K970011 | ESCORT II CLINICAL THERMOMETRY MODULE (CTM) | Medical Data Electronics | 1997-07-09 | 188 | 0 |
| K970012 | ESCORT LINK CENTRAL STATION MONITOR | Medical Data Electronics | 1997-06-26 | 175 | 0 |
| K961138 | ESORT II + 400 SERIES MONITOR | Medical Data Electronics | 1996-12-10 | 264 | 0 |
| K943256 | CARDIAC OUTPUT OPTION 39 | Medical Data Electronics | 1994-12-15 | 162 | 0 |
| K930524 | END TIDAL CO2 OPTION B | Medical Data Electronics | 1994-02-07 | 370 | 0 |
| K930004 | ESCORT 100/300 SERIES B PATIENT MONITORS | Medical Data Electronics | 1993-06-23 | 170 | 0 |
| K915153 | ESCORT-LINK ARRHYTHMIA OPTION 23L | Medical Data Electronics | 1992-04-27 | 165 | 0 |
| K914458 | ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION | Medical Data Electronics | 1991-12-09 | 63 | 0 |
| K911665 | ESCORT 300 SERIES | Medical Data Electronics | 1991-08-29 | 139 | 0 |
| K902254 | ESCORT MODEL 400T TELEMETRY ECG MONITOR | Medical Data Electronics | 1990-07-27 | 67 | 0 |
| K902060 | ESCORT MODEL 300 | Medical Data Electronics | 1990-06-11 | 35 | 0 |
| K901591 | ESCORT-LINK (MODEL E3200) | Medical Data Electronics | 1990-05-15 | 40 | 0 |
| K896958 | ESCORT NON-INVASIVE BLOOD PRESSURE OPTION | Medical Data Electronics | 1990-03-13 | 89 | 0 |
| K892120 | ESCORT PULSE OXIMETRY OPTION | Medical Data Electronics | 1989-09-26 | 179 | 0 |
| K884742 | ESCORT NON-INVASIVE BLOOD PRESSURE OPTION | Medical Data Electronics | 1989-02-02 | 80 | 0 |
| K881986 | ESCORT - PORTABLE PATIENT MONITOR | Medical Data Electronics | 1988-07-12 | 61 | 0 |
| K872291 | ESCORT PORTABLE PATIENT MONITOR | Medical Data Electronics | 1987-09-25 | 101 | 0 |
| K854234 | ESCORT ECG MONITOR SIEMENS SIRECUST 466 | Medical Data Electronics | 1986-01-21 | 92 | 0 |
| K852958 | PACEPAC | Medical Data Electronics | 1985-10-11 | 91 | 0 |
| K842716 | MDE ESCORT 1000 & MDE ESCOR 2000 | Medical Data Electronics | 1985-02-08 | 210 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda