FDA product code DRY: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
DRY is the FDA product code for monitor, blood-gas, on-line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4330 and reviewed by the Cardiovascular panel. FDA has cleared 47 510(k) submissions under DRY, 1 in the last five years, from 33 different applicants. The average 510(k) review took 97 days (median 70); 125 days on average over the last three years. FDA has posted 40 recalls for DRY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4330 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 26 |
| 2018 | 3 | 82 |
| 2020 | 1 | 29 |
| 2021 | 1 | 241 |
| 2024 | 1 | 125 |
Compare with all 510(k) review times · Search every DRY clearance
Top DRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spectrum Medical , Ltd. | 7 | 2020-10-02 |
| 3M Company | 3 | 1997-11-06 |
| Terumo Cardiovascular Systems Corporation | 2 | 2024-04-25 |
| Terumo Cardiovascular Systems Corp. | 2 | 2014-07-25 |
| Spectrum Medical, Llp | 2 | 2011-05-31 |
28 more applicants have DRY clearances. See the full list in Caduvo.
Most recent DRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234065 | Terumo Cardiovascular Systems Corporation | CDI OneView Monitoring System | 2024-04-25 | 125 |
| K202154 | Livanova Deutschland, GmbH | B-Capta | 2021-04-01 | 241 |
| K202557 | Spectrum Medical , Ltd. | Quantum Workstation 12 Elite | 2020-10-02 | 29 |
| K182110 | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring System 550 | 2018-11-02 | 88 |
| K181923 | Spectrum Medical , Ltd. | Quantum Workstation 12.1 | 2018-08-17 | 30 |
Recalls for DRY devices
40 product recalls in 18 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-05-28.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code DRY?
DRY is the FDA product code for monitor, blood-gas, on-line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4330 and reviewed by the Cardiovascular panel.
What device class is DRY?
Class II, regulation 21 CFR 870.4330. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRY?
Across 47 cleared submissions the average was 97 days from receipt to decision (median 70).
Which companies have the most DRY clearances?
Spectrum Medical , Ltd. (7); 3M Company (3); Terumo Cardiovascular Systems Corporation (2); Terumo Cardiovascular Systems Corp. (2); Spectrum Medical, Llp (2).
Have DRY devices been recalled?
Yes: 40 product recalls across 18 recall events; the most recent began 2025-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code DRY
- Run a recall and safety report across every DRY manufacturer
- Watch product code DRY 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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