FDA product code DRW: Adaptor, Lead Switching, Electrocardiograph
DRW is the FDA product code for adaptor, lead switching, electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2350 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under DRW, from 6 different applicants. The average 510(k) review took 186 days (median 158).
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Lead Switching, Electrocardiograph |
| Device class | Class II |
| Regulation | 21 CFR 870.2350 |
| 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 DRW clearance
Top DRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Philips Medical Systems | 2 | 2004-01-15 |
| Eaton Medical Group | 2 | 1985-11-08 |
| Siemens Medical Solutions USA, Inc. | 1 | 1994-09-26 |
| Totemite Medical Electronics | 1 | 1987-12-29 |
| Vital Signs, Inc. | 1 | 1986-08-25 |
1 more applicants have DRW clearances. See the full list in Caduvo.
Most recent DRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033513 | Philips Medical Systems | EASI ECG ALGORITHM | 2004-01-15 | 70 |
| K020456 | Philips Medical Systems | EASI 12 LEAD ALGORITHM | 2002-07-09 | 148 |
| K930786 | Siemens Medical Solutions USA, Inc. | EPCOR | 1994-09-26 | 587 |
| K872781 | Totemite Medical Electronics | EASI LEAD SYSTEM CABLE ASSEMBLY | 1987-12-29 | 168 |
| K861981 | Vital Signs, Inc. | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | 1986-08-25 | 95 |
Recalls for DRW devices
openFDA lists no recalls for product code DRW.
Frequently asked questions
What is FDA product code DRW?
DRW is the FDA product code for adaptor, lead switching, electrocardiograph. It is a Class II device, regulated under 21 CFR 870.2350 and reviewed by the Cardiovascular panel.
What device class is DRW?
Class II, regulation 21 CFR 870.2350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRW?
Across 8 cleared submissions the average was 186 days from receipt to decision (median 158).
Which companies have the most DRW clearances?
Philips Medical Systems (2); Eaton Medical Group (2); Siemens Medical Solutions USA, Inc. (1); Totemite Medical Electronics (1); Vital Signs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DRW
- Run a recall and safety report across every DRW manufacturer
- Watch product code DRW 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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