FDA product code DQE: Catheter, Oximeter, Fiber-Optic
DQE is the FDA product code for catheter, oximeter, fiber-optic. It is a Class II device, regulated under 21 CFR 870.1230 and reviewed by the Cardiovascular panel. FDA has cleared 19 510(k) submissions under DQE, from 8 different applicants. The average 510(k) review took 108 days (median 71). FDA has posted 14 recalls for DQE devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Oximeter, Fiber-Optic |
| Device class | Class II |
| Regulation | 21 CFR 870.1230 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 194 |
Compare with all 510(k) review times · Search every DQE clearance
Top DQE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hospira, Inc. | 5 | 2009-09-18 |
| Edwards Lifesciences, LLC | 4 | 2016-06-16 |
| Baxter Healthcare Corp | 3 | 1993-02-22 |
| Oximetrix, Inc. | 3 | 1982-03-25 |
| Edwards Lifescience, LLC | 1 | 2018-02-20 |
3 more applicants have DQE clearances. See the full list in Caduvo.
Most recent DQE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172423 | Edwards Lifescience, LLC | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | 2018-02-20 | 194 |
| K160645 | Edwards Lifesciences, LLC | PreSep Oligon Oximetry Catheter | 2016-06-16 | 101 |
| K140129 | Icu Medical, Inc. | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | 2014-07-02 | 167 |
| K110167 | Edwards Lifesciences, LLC | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | 2011-02-18 | 29 |
| K091268 | Hospira, Inc. | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | 2009-09-18 | 141 |
Recalls for DQE devices
14 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-07-09.
| Year | Recalls |
|---|---|
| 2020 | 8 |
| 2021 | 6 |
Frequently asked questions
What is FDA product code DQE?
DQE is the FDA product code for catheter, oximeter, fiber-optic. It is a Class II device, regulated under 21 CFR 870.1230 and reviewed by the Cardiovascular panel.
What device class is DQE?
Class II, regulation 21 CFR 870.1230. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQE?
Across 19 cleared submissions the average was 108 days from receipt to decision (median 71).
Which companies have the most DQE clearances?
Hospira, Inc. (5); Edwards Lifesciences, LLC (4); Baxter Healthcare Corp (3); Oximetrix, Inc. (3); Edwards Lifescience, LLC (1).
Have DQE devices been recalled?
Yes: 14 product recalls across 3 recall events; the most recent began 2021-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DQE
- Run a recall and safety report across every DQE manufacturer
- Watch product code DQE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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