PWH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Administrations Sets With Neuraxial Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Medical specialty
- General Hospital
- FDA definition
- The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
- Adverse events (MAUDE)
- 2022: 17
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 |
|---|---|---|
| BD Alaris™ Pump Epidural Infusion Set (K221319) | Care Fusion | 2023-07-21 |
| PCEA Syringe Set (K211649) | Baxter Healthcare Corporation | 2021-11-23 |
| CADD Yellow High Volume Administration Set with NRFit connector (K172592) | Smiths Medical Asd, Inc. | 2018-05-17 |
| CADD® Infusion Disposables Portfolio with NRFit™ connectors (K162219) | Smiths Medical Asd, Inc. | 2017-07-20 |
Track PWH automatically
Every clearance here is in the API, with alerts when new ones post.