Marquette Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Marquette Medical Systems, Inc.” (first 1997, latest 1999), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
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 |
|---|---|---|---|
| LOS | 4 | 4 | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
Review panels
Most recent Marquette Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993008 | QUANTITATIVE SENTINEL SYSTEM | HGM | 1999-12-06 | 90 |
| K981024 | QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM) | LOS | 1998-10-06 | 201 |
| K980495 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | LOS | 1998-05-07 | 87 |
| K980299 | APEX OXIMETER | DQA | 1998-04-24 | 87 |
| K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | DSA | 1998-03-16 | 27 |
| K973403 | CARDIOSMART ST | LOS | 1998-03-12 | 184 |
| K974199 | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION | LOS | 1998-02-06 | 88 |
| K973984 | RAC 2A MODULE HOUSING | CCK | 1998-01-16 | 88 |
| K970545 | DASH 1000 PATIENT MONITOR | DSI | 1997-05-08 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Marquette Medical Systems, 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.
- Marquette Electronics, Inc. (82 510(k)s)
- Marquette Medical, Inc. (17 510(k)s)
- Marquette Gas Analysis Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Marquette Medical Systems, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Marquette Medical Systems, Inc.” (first 1997, latest 1999), across 6 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 Marquette Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marquette Medical Systems, Inc. is 88 days.
Which FDA product codes appear under Marquette Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are LOS (device, 4); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 1); DQA (Oximeter, 1).
Next steps
- See all 9 Marquette Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOS, Marquette Medical Systems, 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, 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.