FDA product code DTY: Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
DTY is the FDA product code for sensor, blood-gas, in-line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4410 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under DTY, from 6 different applicants. The average 510(k) review took 124 days (median 126). FDA has posted 2 recalls for DTY devices.
Classification
| Field | Value |
|---|---|
| Device name | Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4410 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DTY clearance
Top DTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiovascular Devices, Inc. | 3 | 1987-02-19 |
| Medtronic, Inc. | 1 | 2010-02-17 |
| International Biophysics Corp. | 1 | 1997-03-20 |
| Medtronic Bio-Medicus, Inc. | 1 | 1996-01-16 |
| 3M Health Care, Ltd. | 1 | 1990-11-05 |
1 more applicants have DTY clearances. See the full list in Caduvo.
Most recent DTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093650 | Medtronic, Inc. | BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM | 2010-02-17 | 84 |
| K963698 | International Biophysics Corp. | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | 1997-03-20 | 185 |
| K954501 | Medtronic Bio-Medicus, Inc. | BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM | 1996-01-16 | 110 |
| K902654 | 3M Health Care, Ltd. | CDI (TM) SYSTEM 100 MONITORING SYSTEM | 1990-11-05 | 143 |
| K900860 | Cardio Metrics, Inc. | PERFUSION MONITOR | 1990-08-14 | 172 |
Recalls for DTY devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-11-01.
Frequently asked questions
What is FDA product code DTY?
DTY is the FDA product code for sensor, blood-gas, in-line, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4410 and reviewed by the Cardiovascular panel.
What device class is DTY?
Class II, regulation 21 CFR 870.4410. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTY?
Across 8 cleared submissions the average was 124 days from receipt to decision (median 126).
Which companies have the most DTY clearances?
Cardiovascular Devices, Inc. (3); Medtronic, Inc. (1); International Biophysics Corp. (1); Medtronic Bio-Medicus, Inc. (1); 3M Health Care, Ltd. (1).
Have DTY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2010-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code DTY
- Run a recall and safety report across every DTY manufacturer
- Watch product code DTY 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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