Marquette Electronics, Inc.: FDA clearances and approvals
Marquette Electronics, Inc. has 82 FDA 510(k) clearances (first 1980, latest 1997), across 24 product codes in 4 review panels. Median 510(k) review time: 134 days.
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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 11 | 11 |
| DPS | Electrocardiograph | 10 | 10 |
| LOS | 9 | 9 | |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 7 | 7 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 5 | 5 |
| DRX | Electrode, Electrocardiograph | 5 | 5 |
| DQA | Oximeter | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 4 | 4 |
| DXJ | Display, Cathode-Ray Tube, Medical | 3 | 3 |
Plus 14 more product codes.
Review panels
- Cardiovascular (60)
- Anesthesiology (11)
- Physical Medicine (1)
- Radiology (1)
Most recent Marquette Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971868 | IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM | MSX | 1997-11-13 | 177 |
| K971683 | WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNET | MSX | 1997-10-22 | 168 |
| K972199 | SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS | DPS | 1997-09-25 | 106 |
| K962547 | CARDIOSERV P | DRO | 1997-03-06 | 251 |
| K963120 | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | DRO | 1997-02-28 | 200 |
| K962827 | ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) | DSI | 1997-02-24 | 220 |
| K964750 | EAGLE 4000 PATIENT MONITOR | LOS | 1997-02-21 | 87 |
| K962551 | CARDIOSERV S | LDD | 1996-11-19 | 144 |
| K960418 | EAGLE PATIENT MONITOR | DSI | 1996-10-02 | 247 |
| K960272 | EAGLE 3000/3100 PATIENT MONITOR | MLD | 1996-10-02 | 258 |
72 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marquette Electronics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Marquette Electronics, Inc. have?
Marquette Electronics, Inc. has 82 FDA 510(k) clearances (first 1980, latest 1997), across 24 product codes in 4 review panels.
How long does FDA take to clear Marquette Electronics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Marquette Electronics, Inc.'s cleared 510(k)s is 134 days.
What devices does Marquette Electronics, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 11); DPS (Electrocardiograph, 10); LOS (device, 9).
Has Marquette Electronics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Marquette Electronics, Inc. Related entities may recall under other names.
Next steps
- See all 82 Marquette Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Marquette Electronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.