DRW
8 FDA 510(k) clearances · Product code
168 daysmedian time to decision
587 days90th percentile
8clearances measured
FDA profile
- Official device name
- Adaptor, Lead Switching, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2350
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EASI ECG ALGORITHM (K033513) | Philips Medical Systems | 2004-01-15 |
| EASI 12 LEAD ALGORITHM (K020456) | Philips Medical Systems | 2002-07-09 |
| EPCOR (K930786) | Siemens Medical Solutions USA, Inc. | 1994-09-26 |
| EASI LEAD SYSTEM CABLE ASSEMBLY (K872781) | Totemite Medical Electronics | 1987-12-29 |
| ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (K861981) | Vital Signs, Inc. | 1986-08-25 |
| PCX-100 PATIENT INPUT LEADWIRE (K851632) | Eaton Medical Group | 1985-11-08 |
| KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (K851627) | Eaton Medical Group | 1985-11-08 |
| LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) (K761210) | Physio-Control Corp. | 1976-12-21 |
Track DRW automatically
Every clearance here is in the API, with alerts when new ones post.