FDA product code DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DRT is the FDA product code for monitor, cardiac (incl. cardiotachometer & rate alarm). It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel. FDA has cleared 339 510(k) submissions under DRT, 9 in the last five years, from 161 different applicants. The average 510(k) review took 123 days (median 90); 135 days on average over the last three years. FDA has posted 11 recalls for DRT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class II |
| Regulation | 21 CFR 870.2300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 58 |
| 2018 | 1 | 298 |
| 2019 | 1 | 309 |
| 2021 | 2 | 264 |
| 2022 | 1 | 446 |
| 2023 | 1 | 315 |
| 2024 | 3 | 211 |
| 2025 | 1 | 89 |
| 2026 | 3 | 104 |
Compare with all 510(k) review times · Search every DRT clearance
Top DRT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hewlett-Packard Co. | 20 | 1992-11-09 |
| Litton Medical Electronics | 17 | 1984-10-29 |
| Ivy Biomedical Systems, Inc. | 10 | 2021-05-14 |
| Nihon Kohden America, Inc. | 10 | 2005-02-03 |
| Life Science Instrumentation, Inc. | 10 | 1985-03-01 |
156 more applicants have DRT clearances. See the full list in Caduvo.
Most recent DRT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261286 | Circadia Health, Inc. | The Circadia C300 System (C300) | 2026-05-20 | 30 |
| K252676 | Circadia Health, Inc. | The Circadia C300 System (C300) | 2026-02-03 | 162 |
| K253388 | Sleepiz AG | Sleepiz One+ (Model 2.5) | 2026-01-28 | 120 |
| K251364 | Sleepiz AG | Sleepiz One+ (2.5) | 2025-07-29 | 89 |
| K234003 | Circadia Technologies, Ltd. | The Circadia C200 System | 2024-05-30 | 163 |
Recalls for DRT devices
11 product recalls in 10 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-08-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code DRT?
DRT is the FDA product code for monitor, cardiac (incl. cardiotachometer & rate alarm). It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel.
What device class is DRT?
Class II, regulation 21 CFR 870.2300. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRT?
Across 339 cleared submissions the average was 123 days from receipt to decision (median 90).
Which companies have the most DRT clearances?
Hewlett-Packard Co. (20); Litton Medical Electronics (17); Ivy Biomedical Systems, Inc. (10); Nihon Kohden America, Inc. (10); Life Science Instrumentation, Inc. (10).
Have DRT devices been recalled?
Yes: 11 product recalls across 10 recall events; the most recent began 2024-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code DRT
- Run a recall and safety report across every DRT manufacturer
- Watch product code DRT 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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