Marquette Medical, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Marquette Medical, Inc.” (first 1987, latest 2003), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 121 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 11 | 11 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| FPD | Tube, Feeding | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
Review panels
Most recent Marquette Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021471 | MARQUETTE HUBER TRAP SAFETY INFUSION SET | FPA | 2003-09-08 | 488 |
| K953008 | INFANT FEEDING TUBE | FPD | 1996-01-11 | 197 |
| K952976 | PLASTIC BLUNT CANNULA | FPA | 1995-09-15 | 80 |
| K920537 | SUBCUTANEOUS INFUSION SET | FPA | 1992-10-13 | 251 |
| K905219 | 4' LOW VOLUME IV EXTENSION SET | FPA | 1991-06-04 | 196 |
| K905218 | 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP | FPA | 1991-06-04 | 196 |
| K905374 | IV EXTENSION SETS WITH .22 MICRON FILTER | FPA | 1991-05-31 | 183 |
| K901089 | LOW VOLUME TRIFURCATED IV EXTENSION SET | FPA | 1990-10-04 | 211 |
| K901088 | LOW VOLUME BIFURCATED IV EXTENSION SET | FPA | 1990-10-04 | 211 |
| K900427 | IV TRIFURCATED EXTENSION SET | FPA | 1990-02-28 | 29 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marquette Medical, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Marquette Medical, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Systems, Inc. (9 510(k)s)
- Marquette Gas Analysis Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Marquette Medical, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Marquette Medical, Inc.” (first 1987, latest 2003), across 5 product codes in 2 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marquette Medical, Inc. is 121 days.
Which FDA product codes appear under Marquette Medical, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 11); FMI (Needle, Hypodermic, Single Lumen, 2); FRN (Pump, Infusion, 2).
Next steps
- See all 17 Marquette Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Marquette Medical, 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.