FDA product code DQO: Catheter, Intravascular, Diagnostic
DQO is the FDA product code for catheter, intravascular, diagnostic. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. FDA has cleared 501 510(k) submissions under DQO, 17 in the last five years, from 204 different applicants. The average 510(k) review took 122 days (median 88); 140 days on average over the last three years. FDA has posted 285 recalls for DQO devices, 83 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Intravascular, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DQO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 169 |
| 2018 | 10 | 188 |
| 2019 | 6 | 138 |
| 2020 | 3 | 85 |
| 2021 | 1 | 253 |
| 2022 | 4 | 177 |
| 2023 | 4 | 82 |
| 2024 | 4 | 155 |
| 2025 | 2 | 127 |
| 2026 | 3 | 138 |
Compare with all 510(k) review times · Search every DQO clearance
Top DQO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cordis Corp. | 28 | 2002-03-20 |
| Boston Scientific Corp | 19 | 2012-09-14 |
| Scimed Life Systems, Inc. | 16 | 1998-08-18 |
| C.R. Bard, Inc. | 16 | 1998-05-15 |
| AngioDynamics, Inc. | 11 | 2018-07-18 |
199 more applicants have DQO clearances. See the full list in Caduvo.
Most recent DQO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261455 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | 2026-06-26 | 56 |
| K252702 | Bioptimal International Pte. , Ltd. | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | 2026-05-28 | 274 |
| K254278 | Spectrum Vascular | Arterial Pressure Monitoring Set/Tray | 2026-03-25 | 85 |
| K250751 | Terumo Corporation | DualView Catheter | 2025-07-17 | 127 |
| K242966 | Gentuity, LLC | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | 2025-01-31 | 127 |
Recalls for DQO devices
285 product recalls in 79 recall events; 83 initiated in the last five years and 84 still open. Most recent: 2026-08-24.
| Year | Recalls |
|---|---|
| 2017 | 14 |
| 2018 | 4 |
| 2019 | 71 |
| 2020 | 6 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 51 |
| 2025 | 1 |
| 2026 | 26 |
Frequently asked questions
What is FDA product code DQO?
DQO is the FDA product code for catheter, intravascular, diagnostic. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is DQO?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQO?
Across 501 cleared submissions the average was 122 days from receipt to decision (median 88).
Which companies have the most DQO clearances?
Cordis Corp. (28); Boston Scientific Corp (19); Scimed Life Systems, Inc. (16); C.R. Bard, Inc. (16); AngioDynamics, Inc. (11).
Have DQO devices been recalled?
Yes: 285 product recalls across 79 recall events; the most recent began 2026-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DQO
- Run a recall and safety report across every DQO manufacturer
- Watch product code DQO 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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