HFN
9 FDA 510(k) clearances · Product code
89 daysmedian time to decision
504 days90th percentile
9clearances measured
FDA profile
- Official device name
- Transducer, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1995: 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 |
|---|---|---|
| Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) | Clinical Innovations, LLC | 2025-05-22 |
| KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER (K974389) | Clinical Innovations, Inc. | 1998-02-19 |
| PRE-FILLED SYRINGE FOR KOALA IUP (K973746) | Clinical Innovations, Inc. | 1997-11-24 |
| INTRAN 500 (K961424) | Utah Medical Products, Inc. | 1996-07-10 |
| STORC INTRAUTERINE PRESSURE CATHETER (K954955) | Clinical Innovations, Inc. | 1996-04-17 |
| INTRAN PLUS (K955443) | Utah Medical Products, Inc. | 1996-02-20 |
| DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (K920375) | Telos Medical Corp. | 1992-10-27 |
| ULTRANS DISPOSABLE INTRAUTERINE (K882224) | Telos Medical Corp. | 1989-10-12 |
| SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (K893503) | Laurel Medical Corp. | 1989-06-12 |
Track HFN automatically
Every clearance here is in the API, with alerts when new ones post.