FDA product code DTQ: Console, Heart-Lung Machine, Cardiopulmonary Bypass
DTQ is the FDA product code for console, heart-lung machine, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4220 and reviewed by the Cardiovascular panel. FDA has cleared 52 510(k) submissions under DTQ, 3 in the last five years, from 22 different applicants. The average 510(k) review took 125 days (median 73). FDA has posted 267 recalls for DTQ devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for DTQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 98 |
| 2018 | 1 | 158 |
| 2019 | 1 | 102 |
| 2021 | 2 | 148 |
| 2023 | 3 | 205 |
Compare with all 510(k) review times · Search every DTQ clearance
Top DTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sorin Group Deutschland GmbH | 8 | 2011-01-20 |
| Terumo Cardiovascular Systems Corporation | 5 | 2023-04-18 |
| 3M Health Care, Sarns | 5 | 1992-07-08 |
| Livanova Deutschland, GmbH | 3 | 2023-08-24 |
| Stoeckert Instrumente | 3 | 2000-08-09 |
17 more applicants have DTQ clearances. See the full list in Caduvo.
Most recent DTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232291 | Livanova Deutschland, GmbH | Essenz HLM, Essenz ILBM | 2023-08-24 | 23 |
| K221895 | Terumo Cardiovascular Systems Corporation | Terumo Advanced Perfusion System 1 | 2023-04-18 | 292 |
| K221373 | Livanova Deutschland, GmbH | Essenz HLM | 2023-03-09 | 301 |
| K210130 | Livanova Deutschland, GmbH | Stockert S5 System | 2021-04-05 | 76 |
| K202125 | Century Hlm, LLC | Century Perfusion System | 2021-03-07 | 219 |
Recalls for DTQ devices
267 product recalls in 116 recall events; 13 initiated in the last five years and 12 still open. Most recent: 2026-01-09.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 4 |
| 2020 | 7 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 8 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DTQ?
DTQ is the FDA product code for console, heart-lung machine, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4220 and reviewed by the Cardiovascular panel.
What device class is DTQ?
Class II, regulation 21 CFR 870.4220. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTQ?
Across 52 cleared submissions the average was 125 days from receipt to decision (median 73).
Which companies have the most DTQ clearances?
Sorin Group Deutschland GmbH (8); Terumo Cardiovascular Systems Corporation (5); 3M Health Care, Sarns (5); Livanova Deutschland, GmbH (3); Stoeckert Instrumente (3).
Have DTQ devices been recalled?
Yes: 267 product recalls across 116 recall events; the most recent began 2026-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DTQ
- Run a recall and safety report across every DTQ manufacturer
- Watch product code DTQ 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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