HEK
5 FDA 510(k) clearances · Product code
128 daysmedian time to decision
176 days90th percentile
5clearances measured
FDA profile
- Official device name
- Monitor, Heart Sound, Fetal, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 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 |
|---|---|---|
| Fetal Doppler (K142769) | Icare Newlife Technologies, Inc. | 2015-03-20 |
| ECHOHEART TRANSVAGINAL DOPPLER PROBE (K060410) | Summit Doppler Systems, Inc. | 2006-04-10 |
| FETAL PULSE DETECTOR MODEL DOP-1 (K902190) | Advanced Medical Systems, Inc. | 1990-10-22 |
| BIODOP(TM) (K883334) | Diagnosis Related Systems, Inc. | 1988-12-15 |
| DOPPLER (UTD-5 & UTD-6) (K771211) | Terumo America, Inc. | 1977-07-14 |
Track HEK automatically
Every clearance here is in the API, with alerts when new ones post.