Marquest Medical Products, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Marquest Medical Products, Inc.” (first 1980, latest 2005), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | 8 | 8 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 4 | 4 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 4 | 4 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| DQA | Oximeter | 2 | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| DWJ | System, Thermal Regulating | 1 | 1 |
Plus 3 more product codes.
Review panels
- Anesthesiology (24)
- General Hospital (5)
- Clinical Chemistry (1)
- Cardiovascular (1)
- Radiology (1)
Most recent Marquest Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050066 | C-CO2 COLORIMETRIC CO2 INDICATOR | CCK | 2005-03-01 | 48 |
| K970478 | SCT 3000 HEATED HUMIDIFIER | BTT | 1997-07-16 | 159 |
| K962223 | WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER | BTT | 1997-01-14 | 218 |
| K962220 | HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER | BZE | 1997-01-14 | 218 |
| K961838 | RESPIRGARD II, SPIROGARD | CAH | 1996-10-18 | 158 |
| K960972 | DISPOSABLE GAS SAMPLING INTERFACE KITS | CCK | 1996-10-18 | 221 |
| K904690 | TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM | DWJ | 1991-02-01 | 108 |
| K903138 | MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM | BTT | 1990-10-11 | 86 |
| K902632 | GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS | CBT | 1990-09-04 | 82 |
| K903307 | TEMP MARQ TEMPERATURE TREND INDICATOR | KPD | 1990-08-17 | 24 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Marquest Medical Products, 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 Marquest Medical Products, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Marquest Medical Products, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Marquest Medical Products, Inc.” (first 1980, latest 2005), across 13 product codes in 5 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 Marquest Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Marquest Medical Products, Inc. is 64 days.
Which FDA product codes appear under Marquest Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are CBT (Arterial Blood Sampling Kit, 8); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 4); CAH (Filter, Bacterial, Breathing-Circuit, 4).
Next steps
- See all 32 Marquest Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBT, Marquest Medical Products, 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.