FDA product code DRI: Monitor, Line Isolation
DRI is the FDA product code for monitor, line isolation. It is a Class I device, regulated under 21 CFR 870.2620 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under DRI, from 3 different applicants. The average 510(k) review took 32 days (median 31). FDA has posted 1 recall for DRI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Line Isolation |
| Device class | Class I |
| Regulation | 21 CFR 870.2620 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DRI clearance
Top DRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datex Division Instrumentarium Corp. | 2 | 1990-07-06 |
| Hmba | 1 | 1982-09-21 |
| Stanco Medical, Inc. | 1 | 1980-10-10 |
Most recent DRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902492 | Datex Division Instrumentarium Corp. | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | 1990-07-06 | 31 |
| K902493 | Datex Division Instrumentarium Corp. | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | 1990-07-06 | 31 |
| K822316 | Hmba | HEART MONITOR BRACELET ALARM | 1982-09-21 | 49 |
| K802326 | Stanco Medical, Inc. | PRESSURE MONITORING LINES | 1980-10-10 | 17 |
Recalls for DRI devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-02-12.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code DRI?
DRI is the FDA product code for monitor, line isolation. It is a Class I device, regulated under 21 CFR 870.2620 and reviewed by the Cardiovascular panel.
What device class is DRI?
Class I, regulation 21 CFR 870.2620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DRI?
Across 4 cleared submissions the average was 32 days from receipt to decision (median 31).
Which companies have the most DRI clearances?
Datex Division Instrumentarium Corp. (2); Hmba (1); Stanco Medical, Inc. (1).
Have DRI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DRI
- Run a recall and safety report across every DRI manufacturer
- Watch product code DRI 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times